navablate clinical investigation plan
device description

Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is for use with the Emprint™ Ablation System with Thermosphere™
Technology for the ablation of lung tissue.  
1 Intravenous (IV) bag spike 2 Drip chamber 3 Pump tubing (orange)
4 Generator connector 5 Ablation catheter handle 6 Top groove 7 Control ring 8 Radiating section 9 Clip Rail The Emprint ablation catheter kit is designed for use with: - Emprint Ablation Generator (required) - Emprint Ablation Pump (required) - Emprint Ablation Cart (required) - Edge™ or Edge™ Firm Tip Extended Working Channel (required)
- Edge Bronchoscope Adapter (required) - Ablation Footswitch (optional) - 1 liter saline (required)
navablate clinical investigation plan
indication for use

The Emprint™ Ablation System with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Emprint™ Ablation System with Thermosphere™ Technology is not intended for use in cardiac procedures.
navablate clinical investigation plan
contraindications

Do not defibrillate a patient with an ablation catheter inserted. Completely remove the catheter from the patient prior to defibrillation. Microwave ablation procedures are not recommended for pregnant patients or patients with cardiac pacemakers or implanted electronic devices. Potential risks to the patient or fetus have not been evaluated. Parts of the body of the patient containing metallic implants should not be treated unless specialized medical advice is obtained.
navablate clinical investigation plan
warning

The ablation catheter kit is supplied sterile. Do not resterilize. Do not use this device if it appears to be damaged.  
en  
This device has been validated and warranted for single-use only. Any re-use, reprocessing, or re-sterilization could result in device failure causing patient or user injury, illness, or death. Re-use, reprocessing, or re-sterilization could cause contamination of the device, which could result in patient infection. Be careful when creating ablation zones near critical structures including but not limited to large vasculature, heart, pleural boundary, esophagus, ductal structures, and the diaphragm.  
Do not touch the catheter radiating section at any time during the application of energy.  
During energy delivery, ensure that the ablation catheter radiating section does not come in contact with tissue other than the intended target, as inadvertent thermal injury may occur.  
Do not activate the ablation catheter while the radiating section is in contact with metal objects or instruments, as inadvertent thermal injury may occur. Fire/Explosion Hazard: Do not use the Emprint ablation system in potentially flammable or explosive room environments.  
The following substances will contribute to increased fire and explosion hazards in the operating room: - Flammable substances such as flammable anesthetics or alcohol-based skin prepping agents and tinctures
- Oxygen enriched atmospheres
- Oxidizing agents such as nitrous oxide (N2 O)
atmospheres Heating associated with microwave energy can provide an ignition source. Observe fire precautions at all times. When using microwave energy in the same room with any of these substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where microwave procedures are performed. Do not look into or place the ablation catheter radiating section near eyes or testes when energized, as this may result in burns or other injuries to the patient or user. Before use with a bronchoscope, verify compatibility and any criteria for safe use defined in the bronchoscope's instructions for use. Ensure that the bronchoscope is either a Type BF or Type CF applied part. When energized bronchoscopes are used with energized endotherapy devices, patient leakage currents may be additive.  
Precaution The Emprint ablation catheter kit should only be used by clinicians and staff properly trained in the use of this technology and its associated warnings and cautions. Clinicians should also be trained in the use of image guidance technology such as computed tomography (CT) or cone beam CT for the placement of ablation devices.
navablate clinical investigation plan
storage

- Store ablation catheters away from moisture and direct heat.  
- Discard products that have passed the use by date displayed on product packaging.
navablate clinical investigation plan
inspection of package contents

Examine the package carefully before opening to confirm its integrity and that the use by date has not passed. Do not use the device if the package is damaged or opened or if the use by date has passed.
navablate clinical investigation plan
instructions for use procedure setup

Precaution The Emprint ablation generator, Emprint ablation pump, Emprint ablation catheter kit, and Emprint ablation cart are designed for use as a single system.  
Failure to understand and follow provided instructions may result in improper functioning of the system and cause injury to the patient or user. The Emprint ablation cart, including the isolation transformer, must be included in the system setup with the Emprint ablation catheter kit.
navablate clinical investigation plan
important

Refer to the Emprint™ Ablation System with Thermosphere™ Technology User's Guide for detailed instructions regarding proper setup and activation of the Emprint generator and pump.  
For ease of use, only remove portions of the device from the packaging tray as instructed below. The ablation catheter packaging is designed so that the catheter components can remain in the packaging until each is needed.  
1. Confirm that the Emprint generator and Emprint pump are set up according to the Emprint™ Ablation System with Thermosphere™ Technology User's Guide.  
2. Plug in the Emprint system.  
3. Remove the rail from the packaging tray and then disconnect the tray lid.  
3 Figure 1  
  
5. Hang a 1L or larger, room temperature sterile saline bag on the Emprint cart. A hook is provided on the left side of the cart.  
6. Remove the white cap from the IV bag spike on the device tubing.  
7. Fully insert the IV bag spike into the port on the saline bag. Confirm the IV bag spike extends well into the main reservoir of the IV bag as shown in *Figure 2*.
4  
  
en 4. Place the ablation catheter packaging on top of the Emprint cart as shown in *Figure 1*.
Figure 2 8. Prime the drip chamber by gently squeezing its sides until it is approximately half full of saline. The blue indicator should be floating near the surface of the saline.  
9. Open the clear pump-head door and insert the orange pump tubing under the pump roller and into the pump roller clamps. Match the arrows on the pump tubing with the arrows on the pump head.  
10. Close the pump-head cover completely. If the cover is not completely closed, the pump will not operate.  
11. Grasp and push the generator connector to attach it to the front panel of the Emprint generator.  
12. Activate the pump by pressing the activation switch on the pump's front panel.  
13. Allow the pump to fully prime the ablation catheter with saline before continuing with the procedure. The catheter is fully primed when there are no air bubbles observed entering the IV bag.
navablate clinical investigation plan
precaution

When the pump is activated, ensure that saline flowing to the catheter is constantly dripping into the drip chamber. The pump circulates saline through the ablation catheter and back into the IV bag. Failure to circulate saline may result in heating of the ablation catheter that could prevent the system from operating properly.  
If the pump is active and the saline is not flowing, the tubing may be damaged or blocked.  
Stop the pump and perform the following troubleshooting steps: - Confirm that the direction of the orange tubing arrows align with the pump head arrows.  
- Confirm that the IV bag spike is inserted well into the main reservoir of the IV bag
(*Figure 2*).  
- Remove and reinsert the orange pump tubing to ensure proper seating of the pump tubing in the pump roller clamps.  
Restart the pump. If saline is still not flowing, replace the ablation catheter. If any portion of the setup is leaking after troubleshooting, replace the ablation catheter.  
14. On the Emprint generator panel, press the power switch to turn on the generator.
navablate clinical investigation plan
warning

Do not activate microwave energy until setup is complete and the ablation catheter radiating section is fully inserted into tissue.
navablate clinical investigation plan
important

If the Emprint generator displays an error during startup, confirm that the ablation catheter generator connector is properly mated to the generator front panel. Refer to the troubleshooting information in the Emprint™ Ablation System with Thermosphere™
Technology User's Guide for additional information.
navablate clinical investigation plan
placing the ablation catheter

1. Place the Edge extended working channel in the desired location and confirm with imaging.  
2. Tighten the Edge bronchoscope adapter prior to inserting the ablation catheter.  
3. Attach the rail to the bronchoscope adapter as shown in *Figure 3*. Align the ridge on the bronchoscope adapter with the indent on the rail and snap into place.  
Precaution Do not attempt to manually bend or reshape the ablation catheter. Be careful not to kink the device as product damage or malfunction may result.  
4. Depress the latch on the ablation catheter handle and remove the protective tube.  
Check the ablation catheter radiating section and ensure that there are no rough surfaces, sharp edges, or protrusions.  
5. Using short, 2 cm strokes, insert the ablation catheter into the extended working channel. Observe the last 3 cm of the ablation catheter insertion using image guidance to ensure that the ablation catheter:
- remains sheathed in the extended working channel.  
- is not severely bent or broken during insertion.  
6. Insert the ablation catheter into the extended working channel until the ablation catheter handle latch locks with the extended working channel handle. When fully inserted, the ablation catheter tip may protrude slightly from the distal end of the extended working channel.  
7. Slide the ablation catheter clip onto the rail.  
8. Attach the ablation catheter clip to the top groove on the ablation catheter handle. Refer to Figure 3.  
9. Verify that a portion of the rail is extending above the top of the clip. This will ensure that the extended working channel is adequately extended outside of the bronchoscope after unsheathing.  
10. Lock the ablation catheter clip to fix the ablation catheter to the bronchoscope. The device setup should now look like the setup shown in *Figure 3, A* (control ring down and lock symbols visible).  
11. Open the bronchoscope adapter to allow movement of the extended working channel in order to unsheathe the ablation catheter.  
12. While using image guidance to monitor the ablation catheter's position, grasp and slide the ablation catheter control ring upward to retract the extended working channel and unsheathe the ablation catheter radiating section. Slide the control ring up until it clicks into place. *Refer to Figure 3, B and B1.*
13. Use image guidance to confirm that:
- the distal end of the extended working channel is extended beyond the bronchoscope (the dark blue portion of the extended working channel should be visible on the bronchoscope view).  
- the ablation catheter radiating section is outside of the extended working channel.  
- the ablation catheter radiating section is fully inserted into the target tissue.
Precaution Failure to ensure that the extended working channel and ablation catheter radiating section is adequately extended beyond the bronchoscope may damage the bronchoscope.  
14. If any ablation catheter forward adjustment is required, pull the control ring down to sheathe the ablation catheter before attempting to adjust the location. *Refer to* Figure 3, A1.  
15. Tighten the bronchoscope adapter.  
  
Precaution Full retraction of the extended working channel is necessary to expose the entire ablation catheter radiating section to the tissue. Ensure that the ablation catheter handle locks into the unsheathed position prior to activation as shown in *Figure 3*, B.  
The ablation catheter is not designed to penetrate tissue beyond the Edge extended working channel. Proper use requires retraction of the extended working channel to unsheathe the ablation catheter radiating section.
navablate clinical investigation plan
warning

Confirm that the ablation catheter radiating section is in direct contact with target tissue or tightly wedged into a peripheral airway
(no air around the radiating section). Failure to do so may result in unintended thermal injury or alter the ablation zone.  
1. Set the Emprint generator's power setting and activation time. Refer to the *Ablation* Zone Examples section for guidance on power and time settings.
navablate clinical investigation plan
en activating the ablation catheter

If the power and time displays do not adjust, confirm proper connection between the ablation catheter generator connector and the Emprint generator front panel. Note that the Emprint ablation catheter limits the Emprint generator to a maximum of 100 watts and 10 minutes. If the Emprint generator displays a symbol, refer to the Emprint™ Ablation System with Thermosphere™ Technology User's Guide for symbol descriptions and instructions.  
2. Press the Emprint generator START/STOP
button or press the footswitch to activate microwave energy to the ablation catheter.
navablate clinical investigation plan
important

Pressing the START/STOP button immediately stops energy delivery in an emergency.  
3. Use image guidance to:
- confirm that the ablation catheter radiating section is not displaced during activation.  
- monitor ablation zone formation.  
Removing the Ablation Catheter 1. When ablation catheter energy delivery is complete, open the bronchoscope adapter to allow movement of the extended working channel.  
2. Grasp and pull down the control ring until it clicks into place to sheathe the radiating section.  
3. Tighten the bronchoscope adapter. 4. Unlock the ablation catheter clip, disconnect the clip from the top groove, and remove it from the rail.  
5. Depress the latch on the ablation catheter and remove the ablation catheter from the extended working channel.  
Warning Do not clean the ablation catheter with any sharp or abrasive objects as damage to the catheter may occur, potentially resulting in saline leakage and possible patient injury.  
6. If ablating another target area, ensure that no rough surfaces are present on the ablation catheter prior to re-insertion.  
7. To avoid an Emprint generator temperature shutoff error, connect a new, room temperature 1L or larger sterile saline bag to the system prior to every ablation.  
After a Procedure 1. Verify that the Emprint generator is not delivering microwave energy to the ablation catheter.  
2. Press the pump activation switch to turn off the pump operation.  
3. Press the Emprint generator power switch to turn it off.  
4. Open the pump head and remove the pump tubing.  
5. Disconnect the used ablation catheter from the Emprint generator. Twist and pull the generator connector to remove it from the front panel.  
6. Dispose of the ablation catheter and saline IV bag in accordance with hospital or clinic protocol.
navablate clinical investigation plan
further information

The *Emprint™ Ablation System with* Thermosphere™ Technology User's Guide provides additional information about the Emprint ablation system components. Refer to the user's guide for information regarding: - Using the system - Other component functions - Disposal - Troubleshooting - Technical specifications - Technical support en
navablate clinical investigation plan
ablation zone examples

The ablation zone results examples contained in *Table 1* were developed using the ablation catheter kit in an in vivo porcine lung. The table includes the ablation diameter (A), height (B), and distance from the tip (C) versus time (MM:SS) for three power levels (45 watts, 75 watts, and 100 watts). The circular areas in *Figure 4* represent the zone of tissue coagulation created around the ablation catheter radiating section. The shape and size of ablation zones may vary in clinical settings.  
| 45 W    | 75 W   | 100 W   |        |       |        |        |       |        |        |
|---------|--------|---------|--------|-------|--------|--------|-------|--------|--------|
| A       | MM:SS  | B       | C      | MM:SS | B      | C      | MM:SS | B      | C      |
| 1.6 cm  | 2:00   | 2.8 cm  | 0.6 cm |       |        |        |       |        |        |
| 1.9 cm  | 3:00   | 3.0 cm  | 0.7 cm | 2:00  | 3.1 cm | 0.8 cm |       |        |        |
| 2.2 cm  | 4:30   | 3.3 cm  | 0.8 cm | 2:30  | 3.3 cm | 0.9 cm |       |        |        |
| 2.5 cm  | 7:30   | 3.5 cm  | 0.9 cm | 3:30  | 3.6 cm | 0.9 cm | 2:30  | 3.3 cm | 0.7 cm |
| 2.7 cm  | 10:00  | 3.6 cm  | 1.0 cm | 4:30  | 3.8 cm | 1.0 cm | 3:00  | 3.5 cm | 0.8 cm |
| 2.9 cm  | 5:30   | 3.9 cm  | 1.1 cm | 4:00  | 3.7 cm | 0.8 cm |       |        |        |
| 3.1 cm  | 7:00   | 4.0 cm  | 1.1 cm | 5:00  | 3.9 cm | 0.9 cm |       |        |        |
| 3.3 cm  | 9:00   | 4.1 cm  | 1.1 cm | 7:00  | 4.0 cm | 1.0 cm |       |        |        |
| 3.4 cm  | 10:00  | 4.2 cm  | 1.1 cm | 8:30  | 4.1 cm | 1.0 cm |       |        |        |
| 3.5 cm  | 10:00  | 4.2 cm  | 1.0 cm |       |        |        |       |        |        |
| Table 1 |        |         |        |       |        |        |       |        |        |  
Table 1 In Vivo Porcine Lung  
  
  
  
Document No. DLB00794-01 Rev. A Part No. PLB00555-01 Rev. A
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company, ™* brands are trademarks of their respective owner.  
© 2014 Covidien.  
Covidien llc, 15 Hampshire Street Mansfield, MA 02048 USA.  
Covidien Ireland Limited IDA Business and Technology Park, Tullamore.  
Made in USA. Printed in USA. www.covidien.com REV 2016-06  
  
2 1 CA108L1 XXXXXXXXX  
3  
| INCLUDED LANGUAGES                                                                                                                                                                                                                                                                                                       |                                           |               |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------|
| EN                                                                                                                                                                                                                                                                                                                       | ENGLISH                                   |               |
| FR                                                                                                                                                                                                                                                                                                                       | FRENCH-EU                                 |               |
| PT                                                                                                                                                                                                                                                                                                                       | PORTUGUESE-BRAZIL                         |               |
| DE                                                                                                                                                                                                                                                                                                                       | GERMAN                                    |               |
| ES                                                                                                                                                                                                                                                                                                                       | SPANISH-EU                                |               |
| IT                                                                                                                                                                                                                                                                                                                       | ITALIAN                                   |               |
| NL                                                                                                                                                                                                                                                                                                                       | DUTCH                                     |               |
| SV                                                                                                                                                                                                                                                                                                                       | SWEDISH                                   |               |
| RU                                                                                                                                                                                                                                                                                                                       | RUSSIAN                                   |               |
| ZH                                                                                                                                                                                                                                                                                                                       | CHINESE-SIMPLIFIED                        |               |
| CS                                                                                                                                                                                                                                                                                                                       | CZECH                                     |               |
| DA                                                                                                                                                                                                                                                                                                                       | DANISH                                    |               |
| KO                                                                                                                                                                                                                                                                                                                       | KOREAN                                    |               |
| NO                                                                                                                                                                                                                                                                                                                       | NORWEGIAN                                 |               |
| PL                                                                                                                                                                                                                                                                                                                       | POLISH                                    |               |
| TR                                                                                                                                                                                                                                                                                                                       | TURKISH                                   |               |
| ZH-T CHINESE-TRADITIONAL                                                                                                                                                                                                                                                                                                 |                                           |               |
| PRODUCT INFORMATION                                                                                                                                                                                                                                                                                                      |                                           |               |
| Product Brand                                                                                                                                                                                                                                                                                                            | Emprint™                                  |               |
| Product Descriptor 1 Ablation Catheter Kit with  Thermosphere™ Technology Product Descriptor 2 Bronchoscopic Ablation Catalog Number CA108L1 Size n/a LABEL INFORMATION Art Specification DLB00943-01 Rev. A Part Number PLB00678-01 Rev. A GTIN 10884521543461 Product Quantity n/a Label Applied to Outer Shipping Box | LABEL CALLOUTS                            |               |
| 1 Catalog number 2 Batch code* 3 Use by YYYY-MM-DD* 4 Date of manufacture YYYY-MM-DD*                                                                                                                                                                                                                                    | 15 Hampshire Street,  Mansfield, MA 02048 |               |
| GBU-SPECIFIC INFORMATION                                                                                                                                                                                                                                                                                                 |                                           |               |
| Graphic Designer                                                                                                                                                                                                                                                                                                         | David Klein                               |               |
| TECHNICAL INFORMATION                                                                                                                                                                                                                                                                                                    |                                           |               |
| GS1-128 Barcode*                                                                                                                                                                                                                                                                                                         |                                           |               |
| 5 (01) GTIN* (17) Use by YYMMDD* (10) Batch code*  6 - Label part number - Date of revision                                                                                                                                                                                                                              | Application/ Version                      | InDesign/CC   |
| Placed Images                                                                                                                                                                                                                                                                                                            | Embedded                                  |               |
| Fonts Used                                                                                                                                                                                                                                                                                                               | Myriad Pro                                |               |
| *Not included in the png file - added during on-demand label printing.                                                                                                                                                                                                                                                   | PNG                                       |               |
| File Exported                                                                                                                                                                                                                                                                                                            | - Grayscale                               |               |
| for Printing                                                                                                                                                                                                                                                                                                             | - 300 dpi  - No transparency              |               |
| Measurement                                                                                                                                                                                                                                                                                                              |                                           |               |
| Artwork Key                                                                                                                                                                                                                                                                                                              | Die                                       | COMMENTS      |
| Please review the accompanying PNG file that is used to print the label.                                                                                                                                                                                                                                                 |                                           |               |
| Print Process                                                                                                                                                                                                                                                                                                            | On-Demand                                 |               |
| Corner Radius                                                                                                                                                                                                                                                                                                            | n/a                                       |               |
| Label Size                                                                                                                                                                                                                                                                                                               | 4" width x 6" height                      | PRINTER NOTES |  
Bronchoscopic Ablation Patient Pain and Satisfaction Survey  
  
As a participant in the NAVABLATE study, you are being asked to complete this *survey. Please take a few* minutes to complete the form. The information you provide will be used to evaluate patients' satisfaction with the Bronchoscopic Ablation procedure.  
Date Survey Completed: ___________________  
  
Using the scale above as a guide, *please* circle the number that best fits your  
answer:  
Immediately after the Bronchoscopic Ablation procedure?  
  
| Immediately after the Bronchoscopic Ablation  procedure?                                                                                                        |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| because of the Bronchoscopic Ablation procedure:  One week after the Bronchoscopic Ablation  procedure?  One month after the Bronchoscopic Ablation  procedure? |  
One week after the Bronchoscopic Ablation  
procedure?  
One month after the Bronchoscopic Ablation  
procedure?  
Grade Degree of breathlessness related to activities (MRC Breathlessness Scale)*
1 Not troubled by breathlessness except on strenuous exercise 2 Short of breath when hurrying on the level or walking up a slight hill 3 Walks slower than most people on the level, stops after 1.5 kilometers or so, or stops after 15 minutes walking at own pace 4 Stops for breath after walking about 100 meters or after a few minutes on level ground 5 Too breathless to leave the house, or breathless when undressing Version 2.0 01Jun18 NAVABLATE Study Page 1 of 2  
| Using the scale above as a guide, please  circle the number that best fits your  answer:          |    |    |    |    |    |
|---------------------------------------------------------------------------------------------------|----|----|----|----|----|
| Immediately after the Bronchoscopic Ablation  procedure?                                          | 1  | 2  | 3  | 4  | 5  |
| One week after the Bronchoscopic Ablation  procedure?                                             | 1  | 2  | 3  | 4  | 5  |
| One month after the Bronchoscopic Ablation  procedure?                                            | 1  | 2  | 3  | 4  | 5  |
| What level of breathlessness did you experience because  of the Bronchoscopic Ablation procedure: |    |    |    |    |    |  
| Please circle the number that best fits your answer Extremely  Unlikely Neutral Likely                                                                                           | Extremely   |    |    |    |    |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----|----|----|----|
| Unlikely                                                                                                                                                                         | Likely      |    |    |    |    |
| How likely would you be willing to  have an Bronchoscopic Ablation procedure performed again if  necessary?                                                                      | 1           | 2  | 3  | 4  | 5  |
| How likely would you recommend the Bronchoscopic Ablation procedure to family and friends if  necessary?                                                                         | 1           | 2  | 3  | 4  | 5  |
| Please circle the number that best fits your answer Totally  Dissatisfied Neutral Satisfied                                                                                      | Extremely   |    |    |    |    |
| Dissatisfied                                                                                                                                                                     | Satisfied   |    |    |    |    |
| Overall, how satisfied were you  with the Bronchoscopic Ablation                                                                                                                 | 1           | 2  | 3  | 4  | 5  |
| procedure? Printed name of person completing this worksheet: ___________________________________ Signature: ______________________________________________ Date: _______________ |             |    |    |    |    |  
* Used with the permission of the Medical Research Council and adapted to include metric distance units.  
References: 1959 MRC Dyspnoea scale / MRC Breathlessness scale London, UK: Medical Research Council, Accessed: June 1, 2018. Available at:
https://mrc.ukri.org/research/facilities-and-resources-for-researchers/mrc-scales/mrc-dyspnoea-scale-mrc-breathlessness-scale/, and Stenton C. The MRC breathlessness scale. Occupational medicine (Oxford, England). 2008; 58(3):226-227.  
Health Questionnaire  
  
English version for the UK
(Validated for Ireland)
By placing a tick in one box in each group below, please indicate which statements best describe your own health state today.
navablate clinical investigation plan
mobility

I have no problems in walking about I have some problems in walking about I am confined to bed  
| Self-Care   |
|-------------|  
I have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself Usual Activities *(e.g. work, study, housework, family or leisure activities)*
I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities  
| Pain / Discomfort   |
|---------------------|  
I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort  
| Anxiety / Depression   |
|------------------------|  
I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed To help people say how good or bad a health state is, we have drawn a scale (rather like a thermometer) on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0. We would like you to indicate on this scale how good or bad your own health is today, in your opinion. Please do this by drawing a line from the box below to whichever point on the scale indicates how good or bad your health state is today.  
9 0 8 0  
  
0 Worst imaginable health state 100 3
navablate adverse event reference list
navablate adverse event reference list

| __                                                                                                                                       |
|------------------------------------------------------------------------------------------------------------------------------------------|
| Table of Contents                                                                                                                        |
| Common Terminology Criteria for Adverse Events (CTCAE) .                                                                                 |
| Instrumental Activities of Daily Living.                                                                                                 |
| Self-Care Activities of Daily Living .                                                                                                   |
| Adverse Event and Device Deficiency Definitions                                                                                          |
| Adverse Event (AE)                                                                                                                       |
| Serious Adverse Event (SAE)                                                                                                              |
| Adverse Device Effect (ADE)                                                                                                              |
| Serious Adverse Device Effect (SADE)                                                                                                     |
| Unanticipated Serious Adverse Device Effect (USADE)                                                                                      |
| Device Deficiency                                                                                                                        |
| Adverse Event Relationship and Outcome Classifications ..........................................................................4       |
| Adverse Event Relationship Classification                                                                                                |
| Adverse Event Outcome Classification .                                                                                                   |
| Potential Adverse Events and Definitions ..............................................................................................6 |
| A A                                                                                                                                      |
| Bronchopleural Fistula .                                                                                                                 |
| Bronchopulmonary Hemorrhage                                                                                                              |
| Burn                                                                                                                                     |
| Cavitation .                                                                                                                             |
| DEATH                                                                                                                                    |
| HEMATOMA .                                                                                                                               |
| Hemolysis                                                                                                                                |
| Hemoptysis .                                                                                                                             |
| H HEMOTHORAX .                                                                                                                           |
| LUNG Abscess .                                                                                                                           |
| Pleural Effusion .                                                                                                                       |
| Pleural Thickening .                                                                                                                     |
| Pneumonia                                                                                                                                |
| Pneumothorax .                                                                                                                           |  
| Post-Ablation Syndrome 10 Post-Procedure Pain 10 Pulmonary Edema 11 Pyothorax 11 Ventricular Arrhythmia 11   |
|--------------------------------------------------------------------------------------------------------------|
navablate adverse event reference list
common terminology criteria for adverse

A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.  
The CTCAE system is a product of the US National Cancer Institute Cancer Therapy Evaluation Program. This protocol will use Version 5.0 (published 27-NOV-2017), available at https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm\#ctc_50https://ctep.  
cancer.gov/protocolDevelopment/electronic_applications/ctc.htm\#ctc_50
navablate adverse event reference list
instrumental activities of daily living

For the purpose of defining CTCAE grade, instrumental activities of daily living (ADL) refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.
navablate adverse event reference list
self-care activities of daily living

For the purpose of defining CTCAE grade, self-care activities of daily living (ADL) refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
navablate adverse event reference list
adverse event and device deficiency

An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.*
*For the purposes of this clinical study, AE definitions will be ISO 14155:2011 compliant with the following exception: only those adverse events that are related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures will be captured and reported.  
NOTE 1: This definition includes events related to the investigational medical device or the comparator. NOTE 2: This definition includes events related to the procedures involved.  
NOTE 3: For users or other persons, this definition is restricted to events related to investigational medical devices.
navablate adverse event reference list
serious adverse event (sae)

For the purposes of this study, a Serious Adverse Event* is an adverse event that has 1. Led to death, 2. Led to serious deterioration in the health of the subject, that either resulted in  
a. A life-threatening illness or injury, or b. A permanent impairment of a body structure or a body function, or c. In-patient or prolonged hospitalization, or d. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.  
3. led to fetal distress, fetal death or a congenital abnormality or birth defect
NOTE 1: This includes device deficiencies that might have led to a serious adverse event if a) suitable action had not been taken or b) intervention had not been made or c) if circumstances had been less fortunate. These are handled under the SAE reporting system.  
NOTE 2: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational plan, without serious deterioration in health, is not considered a serious adverse event.  
*For the purposes of this clinical study, SAE definitions will be ISO 14155:2011 compliant with the following exception: only those SAEs that are related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures will be captured and reported.
navablate adverse event reference list
adverse device effect (ade)

An Adverse Device Effect (ADE) is an adverse event related to the use of the investigational medical device (the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology).  
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical device.
navablate adverse event reference list
serious adverse device effect (sade)

A Serious Adverse Device Effect (SADE) is an adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.
navablate adverse event reference list
unanticipated serious adverse device effect

An Unanticipated Serious Adverse Device Effect (USADE) is defined as serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the Risk Management Report.
navablate adverse event reference list
device deficiency

Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.  
Note: Device deficiencies include malfunctions, use errors, and inadequate labelling.
navablate adverse event reference list
adverse event relationship and outcome

Causality assessments define the relationship between the use of the medical device (including the procedure) and the occurrence of each adverse event. During causality assessment activity, clinical judgment shall be used and the relevant documents, such as the MDR Reportable Event Trend & Risk Analysis Report shall be consulted, as all the foreseeable serious adverse events and the potential risks are listed and assessed there. The presence of confounding factors, such as concomitant medication/treatment, the natural history of the underlying disease, other concurrent illness or risk factors shall also be considered.  
Each AE and SAE will be classified according to five different levels of causality. The following definitions will be used to assess the relationship of the adverse event to the investigational medical device (the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology), accessory devices, or procedures:  
- *Not related*: Relationship to the device or procedures can be excluded when:
o the event is not a known side effect of the product category the device belongs to or of similar devices and procedures o the event has no temporal relationship with the use of the investigational device or the procedures; o the serious event does not follow a known response pattern to the medical device (if the response pattern is previously known) and is biologically implausible; o the discontinuation of medical device application or the reduction of the level of activation/exposure - when clinically feasible - and reintroduction of its use (or increase of the level of activation/exposure), do not impact on the serious event; o the event involves a body-site or an organ not expected to be affected by the device or procedure; o the serious event can be attributed to another cause (e.g. an underlying or concurrent illness/
clinical condition, an effect of another device, drug, treatment or other risk factors);
o the event does not depend on a false result given by the investigational device used for diagnosis, when applicable; o harms to the subject are not clearly due to use error; o In order to establish the non-relatedness, not all the criteria listed above might be met at the same time, depending on the type of device/procedures and the serious event.  
- *Unlikely*: The relationship with the use of the device seems not relevant and/or the event can be reasonably explained by another cause, but additional information may be obtained.  
- *Possible*: The relationship with the use of the investigational device is weak but cannot be ruled out completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of another device, drug or treatment). Cases were relatedness cannot be assessed or no information has been obtained should also be classified as possible.  
- *Probable*: The relationship with the use of the investigational device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be
obtained.  
- *Causal relationship*: The serious event is associated with the investigational device or with procedures beyond reasonable doubt when:
o the event is a known side effect of the product category the device belongs to or of similar devices and procedures; o the event has a temporal relationship with investigational device use/application or procedures; o the event involves a body-site or organ that o the investigational device or procedures are applied to; o the investigational device or procedures have an effect on; o the serious event follows a known response pattern to the medical device (if the response pattern is previously known);
o the discontinuation of medical device application (or reduction of the level of activation/exposure) and reintroduction of its use (or increase of the level of activation/exposure), impact on the serious event (when clinically feasible);
o other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of another device, drug or treatment) have been adequately ruled out; o harm to the subject is due to error in use; o the event depends on a false result given by the investigational device used for diagnosis, when applicable;
- In order to establish the relatedness, not all the criteria listed above might be met at the same time, depending on the type of device/procedures and the serious event.
Events will be distinguished between the serious adverse events related to the device and those related to the procedures (any procedure specific to the clinical investigation). An adverse event can be related both to procedures and the device. Complications of procedures are considered not related if the said procedures would have been applied to the patients also in the absence of device use/application.  
In some particular cases the event may be not adequately assessed because information is insufficient or contradictory and/or the data cannot be verified or supplemented. The sponsor's Medical Monitor and the Investigators will make the maximum effort to define and categorize the event and avoid these situations. Where the Medical Monitor remains uncertain about classifying the serious event, it should not exclude the relatedness and classify the event as "possible".
navablate adverse event reference list
adverse event outcome classification

Outcome of the event will be defined according to the following:
- Fatal: If death was possibly, probably, or causally related to the event  
- Not recovered / not resolved: Subject has exited the study and the AE is ongoing and not expected to resolve
- Recovered / resolved: The event has fully resolved prior to study exit
- Recovered / resolved with sequelae: The event has resolved prior to study exit, but retained pathological conditions resulting from the prior disease or injury
- Recovering / resolving: The subject has exited the study and the AE is ongoing but expected to resolve
- Unknown: The subject has exited the study and the AE outcome is unknown
navablate adverse event reference list
potential adverse events and definitions

A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles.  
Degree of severity will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) grade as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Asymptomatic, intervention not indicated
- Grade 2: Non-urgent medical intervention indicated - Grade 3: Symptomatic, urgent intervention indicated; device (e.g., pacemaker); ablation; new onset
- Grade 4: Life-threatening consequences; embolus requiring urgent intervention
- Grade 5: Death
navablate adverse event reference list
bronchopleural fistula

A disorder characterized by an abnormal communication between a bronchus and the pleural cavity.  
Degree of severity will be classified according to Common Terminology Criteria for Adverse Events
(CTCAE) grade as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Asymptomatic - Grade 2: Symptomatic, invasive intervention not indicated
- Grade 3: Hospitalization; invasive intervention indicated
- Grade 4: Life-threatening consequences; urgent intervention indicated
- Grade 5: Death
navablate adverse event reference list
bronchopulmonary hemorrhage

A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Mild symptoms; intervention not indicated
- Grade 2: Moderate symptoms; medical intervention indicated - Grade 3: Transfusion, invasive intervention indicated (e.g., hemostasis of bleeding site)
- Grade 4: Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
- Grade 5: Death
navablate adverse event reference list
burn

Unintended microwave burn - unintended tissue ablation Unintended microwave burn - vessel thrombosis /thrombus /embolism Unintended microwave burn - diaphragmatic paresis  
A finding of impaired integrity to the anatomic site of an adverse thermal reaction. Burns can be caused by exposure to chemicals, direct heat, electricity, flames and radiation. The extent of damage depends on the length and intensity of exposure and time until provision of treatment. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates "or" within the description of the grade):
- Grade 1: Minimal symptoms; intervention not indicated
- Grade 2: Medical intervention; minimal debridement indicated
- Grade 3: Moderate to major debridement or reconstruction indicated
- Grade 4: Life-threatening consequences; hemodynamic compromise
- Grade 5: Death
navablate adverse event reference list
hematoma

A disorder characterized by a localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates "or" within the description of the grade):
- Grade 1: Mild symptoms; intervention not indicated - Grade 2: Minimally invasive evacuation or aspiration indicated
- Grade 3: Transfusion; invasive intervention indicated
- Grade 4: Life-threatening consequences; urgent intervention indicated
- Grade 5: Death
navablate adverse event reference list
hemolysis

A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane destruction. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates "or" within the description of the grade):
- Grade 1: Laboratory evidence of hemolysis only (e.g., direct antiglobulin test; DAT; Coombs';
schistocytes; decreased haptoglobin)
- Grade 2: Evidence of hemolysis and >=2 g decrease in hemoglobin
- Grade 3: Transfusion or medical intervention indicated (e.g., steroids)
- Grade 4: Life-threatening consequences; urgent intervention indicated
- Grade 5: Death
navablate adverse event reference list
hemoptysis

Coughing up of blood or blood-stained mucous from the lung. Degree of severity will be classified according to CTCAE general guidelines as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.  
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
- Grade 4: Life-threatening consequences; urgent intervention indicated.  
- Grade 5: Death related to AE.
navablate adverse event reference list
hemothorax

A hemothorax is a type of pleural effusion in which blood accumulates in the pleural cavity. Degree of severity will be classified according to CTCAE general guidelines as follows (a semicolon indicates "or" within the description of the grade):
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.  
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
- Grade 4: Life-threatening consequences; urgent intervention indicated. - Grade 5: Death related to AE.
navablate adverse event reference list
lung abscess

Lung abscess is a pus-filled cavity in the lung surrounded by inflamed tissue and caused by an infection.  
Degree of severity will be classified according to CTCAE general guidelines as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.  
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
- Grade 4: Life-threatening consequences; urgent intervention indicated.
navablate adverse event reference list
- grade 5 death related

A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough and marked chest discomfort. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated
- Grade 2: Symptomatic; intervention indicated (e.g., diuretics or therapeutic thoracentesis)
- Grade 3: Symptomatic with respiratory distress and hypoxia; operative intervention including chest tube or pleurodesis indicated
- Grade 4: Life-threatening respiratory or hemodynamic compromise; intubation or urgent intervention indicated
- Grade 5: Death
navablate adverse event reference list
pleural thickening

Pleural thickening is a descriptive term given to describe any form of thickening involving either the parietal or visceral pleura. Degree of severity will be classified according to CTCAE general guidelines as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.  
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
- Grade 4: Life-threatening consequences; urgent intervention indicated. - Grade 5: Death related to AE.
navablate adverse event reference list
pneumonia

A bacterial, viral, or fungal infection causing inflammation of the lungs. Degree of severity will be classified according to CTCAE grades for Lung Infection as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Not applicable
- Grade 2: Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
- Grade 3: IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated  
- Grade 4: Life-threatening consequences; urgent intervention indicated
- Grade 5: Death
navablate adverse event reference list
pneumothorax

A disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the lung. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates
"or" within the description of the grade):
- Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated
- Grade 2: Symptomatic; intervention indicated (e.g., tube placement without sclerosis)
- Grade 3: Sclerosis and/or operative intervention indicated; hospitalization indicated
- Grade 4: Life-threatening consequences; urgent intervention indicated
- Grade 5: Death
navablate adverse event reference list
post-ablation syndrome

A transient, self-limiting symptom/sign complex of low-grade fever, nausea, vomiting, and general malaise. Most patients who experience this syndrome will experience some malaise for 2-7 days, depending on the tumor volume, volume of ablation zone necrosis, and the integrity of the patient's immune system. Degree of severity will be classified according to CTCAE general guidelines as follows (a semicolon indicates "or" within the description of the grade):
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.  
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
- Grade 4: Life-threatening consequences; urgent intervention indicated.  
- Grade 5: Death related to AE.
navablate adverse event reference list
post-procedure pain

Post-procedure pain will be evaluated both by a Bronchoscopic Ablation Patient Pain and Satisfaction Survey (see Appendix 17.4 of the CIP) and according to the CTCAE general guidelines as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.  
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
- Grade 4: Life-threatening consequences; urgent intervention indicated.  
- Grade 5: Death related to AE.
navablate adverse event reference list
pulmonary edema

A disorder characterized by accumulation of fluid in the lung tissues that causes a disturbance of the gas exchange that may lead to respiratory failure. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates "or" within the description of the grade):
- Grade 1: Radiologic findings only; minimal dyspnea on exertion
- Grade 2: Moderate dyspnea on exertion; medical intervention indicated; limiting instrumental ADL
- Grade 3: Severe dyspnea or dyspnea at rest; oxygen indicated; limiting self-care ADL
- Grade 4: Life-threatening respiratory compromise; urgent intervention or intubation with ventilatory support indicated
- Grade 5: Death
navablate adverse event reference list
pyothorax

An infection in the chest cavity. Degree of severity will be classified according to CTCAE general guidelines as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.  
- Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.  
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
- Grade 4: Life-threatening consequences; urgent intervention indicated. - Grade 5: Death related to AE.
navablate adverse event reference list
ventricular arrhythmia

A disorder characterized by a dysrhythmia that originates in the ventricles. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates "or" within the description of the grade):  
- Grade 1: Asymptomatic, intervention not indicated
- Grade 2: Non-urgent medical intervention indicated
- Grade 3: Urgent intervention indicated
- Grade 4: Life-threatening consequences; hemodynamic compromise - Grade 5: Death
![77image0.png](77image0.png)
ventricular arrhythmia

Master Informed Consent  
Version 2; 06Sep19 Page 1 of 9
![77image0.png](77image0.png)
informed consent template

| Clinical Investigation Plan Title      | Clinical description of a bronchoscopic approach to  ablate lung nodules using the Emprint™ Ablation  Catheter Kit with Thermosphere™ Technology                        |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Investigation Plan Identifier | MDT18010ILSBA                                                                                                                                                           |
| Sponsor/Local Sponsor                  | Medtronic Minimally Invasive Therapies Group (MITG) Surgical Innovations (SI), Lung Health 161 Cheshire Lane, Suite 100 Plymouth, MN 55441                              |
| Principal Investigator:                | Full PI Name (Leave as a placeholder if master  study-specific Informed Consent); if not applicable,  delete row                                                        |
| Clinica l Site:                        | Institution name, address and contact information  (Leave as a placeholder if master study-specific  Informed Consent); if not applicable, mark as 'N/A'  or delete row |
| Study Related Telephone:               | Include telephone numbers to be utilized during  regular office hours as well as outside regular office  hours                                                          |
| Informed Consent Document Version      | Master Consent Template; Version 2; 06Sep19                                                                                                                             |
| Confidentiality Statement              |                                                                                                                                                                         |  
Confidentiality Statement The information contained in this document is confidential and the proprietary property of Medtronic. Any distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is confidential and that it may not be further disclosed by them.  
  
  
Master Informed Consent Version 2; 06Sep19 Page 2 of 9
![77image0.png](77image0.png)
why am i being asked

You are being asked to be in a study that involves clinical research. Being in this study is voluntary. Before you decide if you would like to be in the study, it is important you understand why the study is being conducted and what it will involve. Please read this form carefully and ask your doctor if you have any questions. Upon reading this form and asking any questions you have, you will sign and date the last page of this form if you decide to be in this study. The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is the device that will be used in your lung ablation procedure. Although this device is approved by regulatory authorities and is commercially available, this procedure is not routinely used in normal clinical care of lung nodules. Only qualified physicians with appropriate training are currently allowed to use it and perform this procedure. If you agree to participating in this study, information will be collected relating to your condition and medical care, including information about your lung ablation procedure.
![77image0.png](77image0.png)
study purpose

The purpose of this study is to look at the safety and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology. Detailed medical information will be collected on you and your ablation procedure. You will also be asked to answer questions that are not typically obtained during normal clinical care.
![77image0.png](77image0.png)
system description

The device being studied is a microwave ablation system called the "Emprint™ Ablation Catheter Kit with Thermosphere™ Technology". This device uses microwave energy to generate heat that can destroy your lung nodule. The device has thermal-control featuresto heat up your lung nodule and a small area around your nodule, while avoiding most of your healthy lung tissue. Imaging systems will be used by your doctor to guide the ablation catheter to your lung nodule. You will be given anesthesia for the procedure.  
How long will I be in the study? How many people will be in the study?  
About 30 will be in this study worldwide. Your participation in the study may last about 1-2 months. The overall study is expected to last a total of 18 months.
![77image0.png](77image0.png)
what are my responsibilities during

- Tell the study doctor about your medical and medication history - Attend all visits scheduled with the study doctor - Call the study doctor's office to reschedule a missed visit as soon as possible - Report any injuries, hospitalizations, emergency room visits, symptoms or complaints to the study doctor or nurse as soon as possible.
![77image0.png](77image0.png)
what will happen if i

If you decide to be in this study, the study doctor and study nurse will collect information about you and your medical history. This includes any medication you currently take and any other information in your medical records related to your condition or treatment that may be relevant to your being in the study.
![79image0.png](79image0.png)
what will happen if i

Master Informed Consent  
Version 2; 06Sep19 Page 3 of 9  
  
  
For this study, your study doctor will schedule 2-3 visits with you. You must make sure that you can come to each visit as scheduled.
![79image0.png](79image0.png)
baseline visit

At this visit the following procedures will be carried out:
- Review of eligibility to participate in this study At this visit the following information will be collected:
- Demographic information (year of birth, gender, etc)
- Medical History such as specific diagnoses, previous lung procedures, smoking history, etc. - General health information - Information on your cancerous lung nodule (Review of your computed tomography scan (also called a CT or "CAT" scan)
- Quality of life survey called the EQ-5D (not typically collected during routine clinical care)
![79image0.png](79image0.png)
procedure visit

At this visit the following procedures will be carried out:
- Confirmation of eligibility to participate in this study (This is when you will be enrolled in the study) - The Bronchoscopic Ablation Procedure (This procedure uses a type of X-ray, called fluoroscopy, and Cone Beam Computed Tomography (CBCT) scans, to help guide the doctor during the procedure)
- Images of your lung will be obtained prior to, during, and after the procedure - Evaluation of your general health At this visit the following information will be collected:
- Procedure and lung nodule information - Current medications
- General health information 1-month / Exit Visit At this visit the following procedures will be carried out:
- Evaluation of your general health - Follow-up computed tomography scan (also called a CT or "CAT" scan)
At this visit the following information will be collected:
- Current medications
- General health information - Quality of life survey called the EQ-5D (not typically collected during routine clinical care) - Bronchoscopic Ablation Patient Pain and Satisfaction Survey (not typically collected during routine clinical care)
![79image0.png](79image0.png)
what are the possible risks

The risks of undergoing an ablation procedure are the same whether you choose to take part in the study or not. It is important to understand that you do not need to take part in the study to receive the ablation procedure. Since the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is commercially available, your doctor will discuss the potential benefits, risks and any alternative options. Should you wish to take part, you will receive separate consent forms:
- one for the study - one for the bronchoscopic ablation procedure as part of your standard care  
  
  
Master Informed Consent Version 2; 06Sep19 Page 4 of 9  
  
  
Potential discomforts or complications associated with ablation procedures are listed below. Previous study assessments have shown these complications occur in less than 1% of patients. If you would like more information on these risks, please ask your doctor.  
- Post-ablation syndrome (a transient, self-limiting symptom/sign complex of low-grade fever, nausea, vomiting, and general malaise)
- Post-procedure pain (pain because of the procedure) - Pneumothorax (abnormal presence of air in the chest cavity causing collapse of the lung)
- Hemothorax (bleeding into the chest cavity)
- Pleural effusion (fluid build-up in the cavity) - Pleural thickening (any form of thickening involving either the parietal or visceral pleura) - Pulmonary edema (fluid buildup in the lungs themselves which causes difficulty breathing)
- Pneumonia (chest infection) - Empyema (infection or pus in the chest cavity) - Lung abscess formation (abscess or collection of pus in the lung) - Hematoma (a blood clot or bruise) - Hemoptysis (coughing up of blood or blood-stained mucus) - Bronchopulmonary hemorrhage (bleeding from the bronchi (windpipes) or lungs)
- Bronchopleural fistula (an abnormal communication between a bronchus and the chest cavity) - Death (end of life) - Atrial fibrillation (a dysrhythmia without discernible P waves and an irregular ventricle response to multiple reentry circuits. The rhythm disturbance originates above the ventricles.)
- Ventricular arrhythmia (abnormal heart rate or rhythm) - Stroke (a decrease or absence of blood supply to the brain resulting in damage to the brain and its functions)
- Damage to other body structures (nerves or vessel damage) - Hemolysis (laboratory test result that indicate red blood cell destruction) - Unintended microwave burn (burn in an area that was not meant to be heated)
You may not take part in this study if you are breastfeeding or pregnant. If you are or you become pregnant, there may be risks to you or your unborn child that are not yet known. There is a possible risk of breach of confidentiality. This risk is minimized by protections described in this document. All records identifying you will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available.
![79image0.png](79image0.png)
radiation risks

The CT scan and the imaging that will be carried out as part of your ablation procedure are part of your routine care. If you take part in this study, you will not undergo any additional imaging procedures. These procedures use ionizing radiation to form images of your body and provide your doctor with other clinical information. Ionizing radiation can cause cell damage that may, after many years or decades, turn cancerous. The chances of this happening to you are the same whether you take part in this study or not.
![79image0.png](79image0.png)
what are the possible benefits

If you agree to be in this study, it is possible that you may not have any direct medical benefits. Possible benefits in addition to a commercially available product include the following:
- The information from this study may benefit other subjects with lung nodules in the future. - If the results of this study are favorable, further studies may be justified to evaluate the potential for improved standard of care using microwave ablation technology in lung nodules for future patients.  
  
  
Version 2; 06Sep19 Page 5 of 9  
  
  
- The information gathered in this study may help doctors to understand how to improve the  
  
management of cancer in the lung. It may lead to improvements in care or to the development of new devices/systems/interventions which may benefit yourself or other patients in the future.
![79image0.png](79image0.png)
what happens when i end

Once you have completed the study, your doctor will continue to monitor you as per standard of care.
![79image0.png](79image0.png)
what other treatment choices do

You do not have to be in this study to be treated for cancer in your lung.  
If you decide not to be in this study, your doctor will discuss with you all the options for medical care, including performing the ablation procedure outside of this study. You may choose no treatment at all.  
You should discuss other treatments and their possible risks and benefits with your doctor.
![79image0.png](79image0.png)
who is paying for this

The study site will receive payment from Medtronic for work involved in collecting study data and managing the study at the site. The sponsor will also pay for any additional test or procedures which are not part of your routine care.
![79image0.png](79image0.png)
what will i have to

Any tests or procedures carried out for study purposes will be provided at no cost to you. Your routine care will be provided by the hospital under standard procedures.
![79image0.png](79image0.png)
what happens if i am

Medtronic maintains appropriate clinical trial liability insurance coverage as required under applicable laws and regulations and will comply with applicable local law and custom concerning specific insurance coverage. If required, a Clinical Trial insurance statement/certificate will be provided to your Medical Institution's Ethics Committee. By agreeing to this, you do not give up any of your legal rights. You do not release the study sponsor, study doctors, or the hospital from responsibility for negligence.
![79image0.png](79image0.png)
do i have the right

Being in this study is voluntary. You may choose not to be in the study or to leave the study at any time for any reason. If you choose not to be in the study, leave the study, or the study is discontinued, this will not result in any penalty and you will not lose any benefits to which you are entitled. Your regular care and your relationship with the hospital or clinic and your doctors will not be affected. You will be told about any new information that may make you change your mind about staying in the study. You may be asked to sign a new consent form if this occurs. You may leave the study simply by telling the study doctor. If you choose to leave the study, or the study is discontinued, there are no specific tests that are required prior to leaving the study.  
The study doctors may take you out of the study without your permission if:
- It is in your best medical interest You are for any reason unable to follow your study doctor's instructions.  
- The study sponsor stops the study if:  
  
  
Master Informed Consent Version 2; 06Sep19 Page 6 of 9  
  
  
o It is in the best interest of your health and the health of other study subjects or o Your study doctor is no longer available to oversee the study and no suitable replacement is found.  
If this happens you will be notified about being removed from the study and you will be provided with an explanation about such decision.  
Use for countries outside Europe:
All of your health data already collected for the study cannot be removed from the study data and will continue to be used as described in this form even after your participation in the study has ended.  
Use for countries in Europe:
All of your health data already collected for the study can still be used by the study sponsor unless you object and ask for deletion of the data.  
It is also important to understand that there is a chance your procedure may start, but the ablation portion may not occur if any new information is obtained during the procedure that disqualifies you from having an ablation procedure (for example a risk to your safety is identified). Signing this consent does not automatically enroll you into the study. If you do sign this consent and don't undergo the ablation procedure, the reason you could not be enrolled will be recorded.
![79image0.png](79image0.png)
what is the role of

Trained Medtronic personnel may be present at the bronchoscopic procedure and at study follow-up visits. The role of the Medtronic person is to give technical support. Authorized sponsor representatives will also check data for accuracy and regulatory purposes.
![79image0.png](79image0.png)
how will the sponsor use

If you decide to participate in the study, Medtronic (including, for purposes of this section, its agents and contractors) and others who work with the study will see health information about you. This consent form governs how your health information is disclosed and used.  
This consent form describes the study, and what Medtronic will do with the study data, including your health information received during the study. Medtronic will keep your health information confidential in accordance with all applicable laws and regulations. Medtronic may use your health information to conduct this research, as well as for additional purposes, such as overseeing and improving the performance of its device, new medical research and proposals for developing new medical products or procedures. Any reports or publications about the study or any other research will not include your name or a description of you. Information received during the study will not be used to market to you; your name will not be placed on any mailing lists or sold to anyone for marketing purposes. Regulations and applicable laws, control Medtronic's work in developing and assuring the safety and quality performance of its medical devices. Medtronic may disclose your health information to U.S. and foreign government authorities responsible for assuring the safety of medical devices. Medtronic also may disclose your health information to Ethics Committees and other persons who are required to watch over the safety and effectiveness of medical products and therapies and the conduct of research. You agree to allow Medtronic to use study data in these ways. You also agree to allow governmental authorities to inspect your health information. To participate in the study, you will need to sign this consent form.
![79image0.png](79image0.png)
where can i find out

A description of this study will be available on http://www.ClinicalTrials.gov. This website will not include information that can identify you. At most, the website (databases) will include a summary of the  
  
  
  
Master Informed Consent Version 2; 06Sep19 Page 7 of 9  
  
results. You can consult the general outcome and results of this study after they have been made publicly available by consulting this website.  
Who can I call with questions, complaints or if I'm concerned about my rights as a participant?  
If you have any questions about the research or being in this study, you should contact insert name at insert telephone number.  
If you think you have a research-related injury, you should contact insert name at insert telephone number.  
If you have any questions about your rights as a participant you should contact insert name at insert telephone number.  
Who has reviewed the study?  
This study was reviewed and approved by the insert name of committee Research Ethics Committee.  
  
  
Master Informed Consent Version 2; 06Sep19 Page 8 of 9
informed consent for the medtronic
navablate clinical study

SUBJECT INFORMED CONSENT FORM SIGNATURE SHEET
- I have read the subject information for this study and my study doctor has answered all my questions regarding the study.  
- I had sufficient time to consider my participation in this study, I am aware that participation in this study is completely voluntary, and I agree to follow the instructions from the study doctor.  
- I realize that I may decide to refuse participation or stop participation at any time without penalty and without affecting the quality of my health care or the relationship with my study doctor.  
- I understand and agree that personal information about me will be collected from my medical records, used and processed (manually and by computer) by the manufacturer of a product used in my treatment or any other designated party that is involved in the study (e.g., hospital, study doctor, regulatory authorities, ethics committees).  
- I understand and agree that representatives from Medtronic, regulatory authorities and the Ethics Committee will be granted direct access to my medical records.  
- I understand and agree that the study doctor(s)/hospital will release the relevant personal information about me for the purpose of the study.  
- I understand that I am entitled to access the personal information collected about me and to have inaccuracies corrected.  
- I agree to voluntarily be in and comply with this study. - I understand that I will receive a dated and signed copy of the subject informed consent form.  
  
Version 2; 06Sep19 Page 9 of 9  
  
It is your choice if you would like your personal physician to be informed of your participation in this study. Please check one of the boxes below to show your choice:
! must be checked by subject  
  
I agree to inform my personal doctor about my participation in this study I do not agree to inform my personal physician about my participation in the study Signature of the subject I agree to be in this study **and I have consented before the initiation of any study** specific procedures. Subject:  
| Name                        | Signature                    | Date (DD/MMM/YYYY)   |
|-----------------------------|------------------------------|----------------------|
| Must be written by subject! | Must be written by  subject! |                      |  
Study doctor or designated person by study doctor:
I have conducted the informed consent discussion.  
| Name                     | Signature                | Date (DD/MMM/YYYY)   |
|--------------------------|--------------------------|----------------------|
| Must be written by study | Must be written by study |                      |
| doctor or delegate!      | doctor or delegate!      |                      |
informed consent for the medtronic
document change history

| Revision                                             | Description of Change                   | Author           |
|------------------------------------------------------|-----------------------------------------|------------------|
| 1.0                                                  | 08-May-2018 First issue                 | Jennifer Wolvers |
| 06-Sep-2019. Updated to be MDR compliant. Updates to |                                         |                  |
| 2.0                                                  | this sample ICF were also made based on | Jennifer Wolvers |
| comments/suggestions from country specific sites.    |                                         |                  |