The Feasibility of Using the Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for the Treatment of Endometriosis
Phase: NA
Conditions: Endometriosis
Sponsor: Mercy Research

 
  
 
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THE FEASIBILITY OF USING THE ULTRAVISION™ SYSTEM TO FACILITATE LOW IMPACT LAPAROSCOPIC 
SURGERY FOR THE TREATMENT OF ENDOMETRIOSIS 
 
PROTOCOL NO.   19-109 (CP-004) 
PROTOCOL VERSION:  1.0 
PROTOCOL VERSION DATE:  21MAY2019 
 
NCT NUMBER:  NCT03956082 
FUNDING AGENCY:  ALESI SURGICAL, LTD. 
  
PRINCIPAL INVESTIGATOR: 
DAVID LEVINE, MD 
 
 
 
 
 
MERCY HOSPITAL ST. LOUIS 
 
 
 
 
 
621 S. NEW BALLAS RD 
 
 
 
 
 
ST. LOUIS, MO  63141-8232 
 
 
 
 
 
314-251-7650 
 
 
 
 
 
DAVID.LEVINE@MERCY.NET 
  
STUDY SITE: 
 
 
  MERCY HOSPITAL ST. LOUIS 
621 S. NEW BALLAS RD 
ST. LOUIS, MO  63141-8232 
 
 
Approvals 
Signature & Approval Date 
 
 
 
 
 
 
 

 
  
 
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1. 
Study Protocol Introduction & Background .............................................. 7 
2. 
Study Purpose ...................................................................................... 9 
3. 
Intended Use (Per Instructions for use)..................................................... 9 
4. 
Device Description ............................................................................... 9 
5. 
US Regulatory Status .......................................................................... 10 
6. 
Study Design ..................................................................................... 11 
7. 
Study Size ......................................................................................... 11 
8. 
Duration............................................................................................ 11 
9. 
Study Endpoints ................................................................................. 11 
10. 
Subject Identification & Selection ......................................................... 12 
10.1. 
Inclusion CriterIa .............................................................................12 
10.2. 
Exclusion Criteria ............................................................................12 
11. 
Subject Informed Consent .................................................................... 13 
12. 
Screening & Enrollment ...................................................................... 14 
13. 
Preoperative Protocol .......................................................................... 14 
14. 
Procedure Protocol ............................................................................. 15 
15. 
Surgeon Visualization Survey............................................................... 16 
16. 
Post Procedure Follow-up Protocol ....................................................... 16 
17. 
Adverse Events .................................................................................. 17 
17.1. 
Adverse Event Categories .................................................................17 
17.2. 
Adverse Event Adjudication ..............................................................18 
17.3. 
Reporting of Adverse Events and Unanticipated Problems .....................18 
17.4. 
Subsequent Surgical Interventions ......................................................18 
18. 
Patient Withdrawal ............................................................................. 18 
19. 
Study Suspension/Termination ............................................................. 19 

 
  
 
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20. 
Study Materials .................................................................................. 19 
21. 
Provision and Inventory of Study Devices .............................................. 19 
22. 
Data Collection and Management.......................................................... 19 
23. 
Imaging Diagnostics ........................................................................... 20 
24. 
Data Analysis Plan.............................................................................. 20 
24.1. 
Sample Size Justification ..................................................................20 
24.2. 
Data Analysis..................................................................................21 
25. 
Training Procedures ............................................................................ 21 
26. 
Administration ................................................................................... 21 
27. 
Regulatory Compliance ....................................................................... 21 
27.1. 
Institutional Review Board ................................................................22 
27.2. 
Good Clinical Practices ....................................................................22 
28. 
Privacy and Confidentiality .................................................................. 22 
29. 
Records and Reports ........................................................................... 22 
29.1. 
Investigator Records.........................................................................22 
29.2. 
Investigator Reports .........................................................................24 
29.3. 
Record Retention .............................................................................24 
30. 
Risk/Benefit Assessment ..................................................................... 24 
31. 
Related Documents ............................................................................. 24 
 
Compliance Statement 
This study will be conducted in full accordance with this protocol, all applicable  Mercy Hospital St. Louis 
Institutional Review Board policies and procedures, International Conference on Harmonization guidelines 
for Good Clinical Practice and all applicable Federal and state laws and regulations including 45 CFR 46 and 
the HIPAA Privacy Rule.  

 
  
 
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THE FEASIBILITY OF USING THE ULTRAVISION™ SYSTEM TO FACILITATE LOW IMPACT LAPAROSCOPIC 
SURGERY FOR THE TREATMENT OF ENDOMETRIOSIS 
 
Study Summary 
Introduction and Background 
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of 
electrostatic precipitation from the visual field during laparoscopic surgical procedures. “Surgical smoke” 
refers to the suspended particulate matter that is generated as a by-product of the combustion and other 
processes that are associated with the use of energy-based surgical instruments. Surgical smoke can obscure 
(partially or totally) the surgeon’s view of the operative field and this has obvious safety implications for the 
patient. In the case of laparoscopic procedures, which are increasing in popularity, the smoke is retained 
within the “closed abdomen” and this, coupled with the CO2 pneumoperitoneum, presents additional 
challenges for the surgical team.  The Ultravision™ System can therefore be considered an accessory to 
electrosurgical instruments to clear the surgical smoke generated during their use and as such will only be 
used when such devices are in use.   
The ability to operate under “low impact” laparoscopic conditions has been shown by others to improve 
clinical outcomes by, for example, reducing post-surgical pain and with smaller incision sizes, improved 
cosmesis.  For the purposes of this study “low impact” is defined as (1) a target pneumoperitoneal pressure of 
10mm Hg; and (2) instead of 10mm and/or 12mm ports, the use of 3mm ports and one 5mm port.  Using a 
standard insufflator, the combination of lower pneumoperitoneal pressure and smaller size ports creates 
visualization challenges for the surgeon due to the difficulty of preventing the buildup of surgical smoke 
within the abdomen.  “Venting” or actively extracting the smoke through a trocar is known to be largely 
ineffective due to the narrow internal diameter of 3mm trocars, certainly unless the instrument is removed 
beforehand, which creates additional surgical challenges. Furthermore, operating under lower pressure can 
cause pneumoperitoneum to be lost upon venting of the smoke.  The research question that is posed in this 
study is whether the Ultravison™ System, due to its unique mode of action which (unlike other smoke 
management approaches) provides smoke management without needing to extract or exchange CO2,  provides 
effective visual field clearing, thereby facilitating low impact laparoscopic surgery when using a conventional 
insufflator.  In addition, Ultravision™ does not require CO2 removal and replacement to achieve its intended 
use, thereby minimizing to the greatest extent possible patient CO2 exposure.  CO2 is dry (effectively 0% 
relative humidity) and cold (typically 65F) and exposure is linked to postoperative pain and other adverse 
consequences such as patient cooling and tissue desiccation.  Due its mode of action, Ultravision™  
minimizes CO2 exposure to the patient. 

 
  
 
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Laparoscopic surgery for the treatment of endometriosis is a common procedure for the removal of mild to 
moderate endometriosis.  Diathermy is commonly used to remove the lesions which can be extensive, 
therefore this procedure presents an appropriate surgical procedure for this study.  
Assessments in terms of surgical field visualization,  CO2 consumption, end tidal CO2, patient satisfaction for 
cosmesis, and postoperative pain will be conducted in order to determine if the Ultravision™ System is 
effective in enabling laparoscopic surgery under low impact laparoscopic conditions.   Adverse event 
information will be reported.  The study is an open label single arm study. 
Study Purpose 
There are five main study objectives: 
1. Demonstrate the feasibility of undertaking low impact laparoscopic surgery for endometriosis when 
using the Ultravision™ System. 
2. Assess the impact of Ultravision on visual field clarity.   
3. Determine the ability to complete the procedure while maintaining an abdominal pressure of < 
10mmHg. 
4. Quantify the consumption of CO2. 
5. Collect data on additional clinical outcomes associated with the use of Ultravision and low impact 
surgery (i.e. end tidal CO2 levels (EtCO2), adverse events, cosmesis outcome, postoperative pain 
levels and pain medications). 
Study Hypothesis 
The primary hypothesis being tested in this study is that Ultravision facilitates the utilization of low impact 
laparoscopic surgery techniques whilst maintaining an adequate visual field throughout the procedure with 
low demand for  CO2 replenishment to maintain pneumoperitoneal pressure.   
Study Population 
The study will enroll patients  indicated for laparoscopic surgery to treat endometriosis.  Patients must meet 
all inclusion/exclusion criteria. 
Study Design 
This is a prospective single arm study.  The study will enroll 20 patients. Comparisons to prior clinical trials 
and published literature will be made to assess the relative significance of the study results. 
Study Endpoints 

 
  
 
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Success will be based on demonstration that the procedures using the Ultravision™ System achieves the 
following endpoints : 
1. The ability to complete the procedure without increasing pneumoperitoneum due to visualization.  
Any increase beyond 10mm Hg and the reason for change will be recorded.   
2. The quality of visualization in the laparoscopic field of view will be assessed by the investigator 
using a Visual Analog Scale (VAS). 
3. Patient satisfaction with cosmesis outcome at the discharge follow-up visit assessed by means of a 
survey scaled from “very unsatisfied” to “very satisfied.” 
4. Post-Surgery Pain assessment based upon a Numerical Rating Scale (NRS) where 0 is “no pain at all” 
to 10 “worst pain imaginable” and the location of the pain using a body diagram.  
5. Pain medication utilization 
Other Data Collection 
• 
End tidal CO2 volume (etCO2) (taken at the start of the procedure and at the completion of the 
procedure), 
• 
Adverse Events, 
• 
Electrosurgical instrument(s) used,  
• 
Preoperative assessment: patient demographics, medical history, medication information, height 
and weight, pain (at intake visit) 
• 
Number of endometriosis lesions resected 
Study Size: 
A sample size of 20 patients should provide a sufficient sample size for comparative analysis to prior clinical 
data relative to Ultravision and published peer reviewed clinical data on laparoscopy and low impact 
laparoscopy. 
Duration of Study: 
The target for the overall duration of the study is four months. 
Data Analysis:  Descriptive  statistics for all endpoints will be applied to analyze the results. 
Results from other studies conducted by Alesi as well as clinical data gleaned from the medical literature will 
be used to assess the relative significance of the study result.

 
  
 
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1. STUDY PROTOCOL INTRODUCTION & BACKGROUND  
The advantages of laparoscopic surgery are generally accepted in the medical community.  However, as with 
any therapy or procedure the unique circumstances associated with this type of surgery are not without 
physiological consequences such as tissue desiccation and postoperative pain. 1 2  The working space created 
by pneumoperitoneum using CO2 is required to create the visual/working field but creates its own concerns 
regarding abdominal pressure and CO2 absorption into the abdominal tissue.3  The smoke generated by 
electrosurgical devices in the process of dissection of tissues during laparoscopy can obscure the surgical 
visual field which can impede the operating surgeon. It is often necessary to suspend the surgery to allow the 
smoke to dissipate, or more commonly open a laparoscopic port to vent the smoke into the room, adding to 
the operating time. It is also common to remove the laparoscope to clean the lens because it can be soiled by 
the smoke as well. In order to enhance the dissipation of smoke and maintain an adequate pneumoperitoneum 
it is often necessary to increase the flow of carbon dioxide (CO2) from the insufflator. Surgical smoke 
handling during laparoscopic surgery results in an increase of the known risks to the patient of using 
excessive CO2 as well as exposing the operating room staff to the smoke which may create a potential health 
concern.   
The Ultravision™ Visual Field Clearing System provides a stable and clear visualization using electrostatic 
precipitation to remove the smoke from the visual field.  This is accomplished with Ultravision   without 
requiring venting of gas, that would otherwise be replaced to maintain the pneumoperitoneum operating 
pressure.  Because it does not rely on gas flow for smoke clearing, CO2 consumption is greatly reduced 
compared to other methods. Safety and feasibility studies have been carried out allowing it to be placed on the 
market in Europe, Japan and the United States. A randomized study of its clinical effectiveness showed that 
electrostatic-precipitation significantly improved visibility (reduction of visual impairment) and reduced 
 
 
1 O’Malley C, Cunningham AJ, Physiologic Changes during laparoscopy, Anesthesiology Clinics of North America, 
2001 Mar; 19(1): 1-19. 
2 Veekash G, Wei LX, Su M, Carbon dioxide pneumoperitoneum, physiologic changes and anesthetic concerns, 
Ambulatory Surgery, 162 July 2010. 
3 Srivastava A, Niranjan A, Secrets of laparoscopic surgery: Anaesthetic and surgical considerations, Journal of 
Minimum Access Surgery, 2010 Oct-Dec; 6(4): 91-94. 

 
  
 
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surgery time in laparoscopic cholecystectomy.4 A similar study in laparoscopic hysterectomy and 
myomectomy reported similar results at lower pneumoperitoneal pressures (10mmHg). 5 
The ability to operate under low impact laparoscopic conditions has been shown by others to improve clinical 
outcomes by, for example, reducing post-surgical pain and improved cosmesis. 6  For the purposes of this 
study “low impact” is defined as (1) a target pneumoperitoneal pressure of 10mm Hg; and (2) the use of 3mm 
ports with one 5mm port.  Using a standard insufflator, the combination of lower pneumoperitoneal pressure 
and smaller size ports creates visualization challenges for the surgeon due to the difficulty of preventing the 
buildup of surgical smoke within the abdomen.  “Venting” or actively extracting the smoke through a trocar is 
known to be largely ineffective due to the narrow internal diameter of 3mm trocars, certainly unless the 
instrument is removed beforehand, which creates additional surgical challenges.  In addition, due to its unique 
mode of action, Ultravision™, unlike other smoke clearing systems, does not require CO2 removal and 
replacement to achieve its intended use.  CO2 exposure is linked to postoperative pain and other adverse 
consequences (i.e. patient cooling, tissue desiccation).  Due its mode of action, Ultravision™  minimizes CO2 
exposure to the patient. 
Laparoscopic surgery for the treatment of endometriosis is a common procedure for the removal of mild to 
moderate endometriosis.  Diathermy is commonly used to remove the lesions which can be extensive, 
therefore this procedure presents an appropriate surgical procedure for this study. Diathermy devices are 
electrosurgical devices that deliver high frequency currents to heat tissue to aid in dissection of tissue and to 
control bleeding. 
 
 
 
 
4 Ansell J., Electrostatic precipitation is a novel way of maintaining visual field clarity during laparoscopic surgery: a 
prospective double-blind randomized controlled pilot study. Surg, Endosc. (2014) 28: 2057-2065) 
5 Levine D., Investigator sponsored research, “ A randomized, controlled study evaluating the effectiveness of the 
Ultravision™ Visual Field Clearing System in laparoscopic hysterectomy and myomectomy,” Mercy Hospital St. Louis, 
November 2018. 
6 Yasir M, Kuldeep MS, Vigar HB, Aiman A, Masood I, Iqbal B, Evaluation of post-operative shoulder tip pain in low 
pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy, The Surgeon, Journal of the 
Royal Colleges of Surgeons of Edinburgh and Ireland, 10(2012) 71-74. 

 
  
 
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2. STUDY PURPOSE  
The research question that is posed in this study is whether the Ultravison™ System provides effective visual 
field clearing thereby enabling low impact laparoscopic surgery when using a conventional insufflator with 
low demand for CO2 replenishment to maintain pneumoperitoneal pressure.      
3. INTENDED USE (PER INSTRUCTIONS FOR USE) 
The Ultravision™ System is indicated for the clearance of smoke and other particulate matter that is created 
during laparoscopic surgery. 
4. DEVICE DESCRIPTION 
The Ultravision™ System is an accessory to electrosurgical instruments that is used to clear the surgical 
smoke generated during their use and as such will only be used when such devices are in use.  An example of 
the effect of the Ultravision™ System during use to improve the visualization of the field of view is 
demonstrated in Figure 2 below: 
 
Figure 1. View before and during cutting with an electrosurgical instrument 
  
Figure 2. Electrosurgical smoke without (left hand image) and with (right hand image) Ultravision. 

 
  
 
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The system includes the following elements: 
Standalone battery-operated generator unit  
 
Figure 3. Ultravision Generator with battery pack 
Ionwand™, which is introduced into the abdomen of the patient through either the Ultravision™ 5mm 
Trocar or a 2.5mm percutaneous catheter and provides the source of the electrons that create the negative ions 
that transiently charge the surgical smoke particles.     
 
Figure 4. Ionwand, sterile assembly in package (top), 5mm Trocar (bottom) 
Other accessories include a patient return adaptor and battery recharging station.   
5. US REGULATORY STATUS 
The Ultravision™ System obtained regulatory clearance through US FDA’s De Novo Classification Process 
(DEN 150022). The system has been in distribution in Europe since January 2014 and in the US since 
December of 2016, over 250 systems are currently in use.  To date there have been no incident or medical 

 
  
 
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device reports (patient injury reports) and there have been no product recalls.  The Ultravision™ System and 
consumable items are being provided for this study free of charge. 
6. STUDY DESIGN 
This is a prospective nonrandomized study in patients undergoing laparoscopic surgery for endometriosis.   
7. STUDY SIZE 
The study will enroll 20 patients.    
8.  DURATION 
The total duration of the study is expected to be approximately four months.  Two months to enroll and two 
months to complete last follow-up visit and study report. 
9. STUDY ENDPOINTS 
To answer the research question posed the following data will be collected: 
1. The ability to complete the procedure without increasing pneumoperitoneum due to visualization.  
Any increase beyond 10mm Hg and the reason for change will be recorded.   
2. The quality of visualization in the laparoscopic field of view will be assessed by the investigator 
using a Visual Analog Scale (VAS). 
3. Patient satisfaction with cosmesis outcome at the discharge follow-up visit assessed by means of a 
survey scaled from “very unsatisfied” to “very satisfied.” 
4. Post-Surgery Pain assessment based upon a Numerical Rating Scale (NRS) where 0 is “no pain at all” 
to 10 “worst pain imaginable” and the location of the pain using a body diagram. 
5. Pain medication utilization  
10. OTHER DATA COLLECTION 
• 
End tidal CO2 volume (etCO2) (taken at the start of the procedure and at the completion of the 
procedure), 
• 
Adverse Events, 
• 
Electrosurgical instrument(s) used,  
• 
Preoperative assessment: patient demographics, medical history, medication information, height 
and weight, pain (at intake visit) 
• 
Number of endometriosis lesions resected 

 
  
 
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11. SUBJECT IDENTIFICATION & SELECTION 
Potential subjects will be identified from the clinical practice of the participating investigator or by their 
respective research staff.  Patients presenting to the clinical practice of the participating investigator for 
diagnosis or treatment consistent with the inclusion criteria will be informed about the study.   
With referral from the treating physician/provider, patients scheduled for surgery prior to the start of the study 
may be contacted via telephone by a study team member to inform them of the study, assess their interest and 
assess their eligibility to participate.  An IRB approved script will be used for such calls.  For interested 
patients, a copy of the informed consent can be mailed or emailed to the patient for their review and 
consideration prior to their next clinic visit or the scheduled procedure.   
Each new subject presenting for evaluation or inclusion is to be assessed for adherence to the following 
inclusion/exclusion criteria. Determination of whether subjects satisfy the criteria may be established by 
review of medical records, subject interview, physical examination, or testing as appropriate. A baseline form 
is used to collect subject screening information and baseline assessments.  Patients are considered enrolled 
once it has been demonstrated that the inclusion/exclusion criteria have been met and the patient signs the 
informed consent.   
The study allows for an intraoperative exclusion for excessive abdominal wall thickness or other anatomical 
characteristics that prevent the use of Ultravision.  If this should occur, the patient will be withdrawn from the 
study.  The withdrawal will be recorded on the withdrawal case report form.  The patient will be replaced. 
11.1. 
INCLUSION CRITERIA 
Subjects MUST meet all the following: 
I1 
Is 18 years or older. 
I2 
Provide written informed consent prior to trial procedures after studies indicate 
that the patient needs the prescribed procedure. 
I3 
Agrees to attend all follow-up assessments. 
I4 
Is indicated for laparoscopic surgery for the treatment of endometriosis. 
I5 
Able to read and understand English 
11.2. 
EXCLUSION CRITERIA 
Subjects MUST not have any of the following: 

 
  
 
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E1 
Existing comorbidities that would contraindicate them for laparoscopic surgery. 
E2 
Patient anatomy that is not compatible with the use of the Ionwand catheter i.e. 
abdominal wall thickness that exceeds the working length of the Ionwand catheter 
identified intraoperatively   
E3 
Patient with a BMI > 50 
E4 
Be pregnant 
  
12. SUBJECT INFORMED CONSENT  
A partial waiver of HIPAA Authorization is being requested for the purposes of initial screening for study 
eligibility and recruitment purposes.   Identifiable health information to be accessed under this waiver will 
include contact information, demographics, and medical history.  Only study team members will have access 
to this information.  Safeguards to maintain privacy and confidentiality of information will be taken as 
described in the data collection and management section of the protocol. Patient inclusion could be 
substantially hindered without the ability to review patients’ records for eligibility and recruitment purposes, 
particularly for patients who may have already been scheduled for surgery at the time the study begins.   
Referred patients presenting for diagnosis or treatment consistent with the inclusion/exclusion criteria will 
undergo the informed consent process to authorize the gathering of data recorded on the Subject Screening & 
Enrollment Form.  The study investigator will administer informed consent or may delegate the responsibility 
to a qualified individual as long as it is defined on the study responsibility log.  When administering consent, 
it must be evident that the participant comprehends the nature of the study and the risks and benefits.  
Evidence is the patient is able to verbalize these topics in sufficient detail to confirm comprehension. 
Completion of the informed consent does not constitute enrollment.  Enrollment occurs once screening is 
complete and all criteria for participation have been met. 
Subjects must document their consent for study participation by signing the Institutional Review Board 
approved Informed Consent Form.  The informed consent process must be consistent with the Declaration of 
Helsinki.  The subject must be given the opportunity to ask questions of, and receive answers from, study 
personnel prior to a request to sign the Informed Consent Form.  This form is to be co-signed by the 
investigator.  Failure to obtain consent prior to subject participation is considered a protocol deviation and 
must be reported to the Institutional Review Board. 

 
  
 
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Note that subjects will be asked to provide consent so that data related to their eligibility status data can be 
gathered. 
After the subject and investigator sign the Informed Consent Form, the original is to be filed in the subject’s 
study binder.  Copies will be filed in the subject’s medical record and the subject is also to be given a copy. 
13. SCREENING & ENROLLMENT 
Patient demographics and other baseline information will be collected to establish whether the patient meets 
the requirements for the study.  It is assumed that a physical exam will be conducted as part of the standard of 
care.  Only limited information on the patient’s health status is collected for the study as defined in Table 1 
below.  Each patient will be assigned a unique study number.  Baseline information will be collected, 
consistent with the standard of care.  Baseline assessment is conducted at the preoperative visit.   
Table 1 
Baseline  Assessment – Conducted at Pre-op visit 
Type of Information 
Data Sources 
Time Frame 
Date of Evaluation 
Investigator Report 
NA 
Subject Age 
Subject interview / Medical Record NA 
Height 
Medical Record 
NA 
Weight 
Medical Record 
NA 
Body Mass Index (BMI) 
Medical Record 
 
Prior/Existing Medical Conditions 
Subject interview & medical record Within three months 
prior to surgery 
Prior/Existing Medical Interventions 
Subject interview & medical record Within three months 
prior to surgery 
Diagnosis Indicating Surgical 
Intervention 
Investigator Report 
Within three months 
prior to surgery 
Current Pain Medications and Reason 
for Taking 
Subject interview & medical record Within three months 
prior to surgery 
14. PREOPERATIVE PROTOCOL 
Patients will be assessed preoperatively in accordance with the current standard of care. 
Table 2 
Pre-Surgery (Intake) Assessment 
 
Type of Information 
Data Sources 
Date of Evaluation 
Investigator Report 
Completed Informed Consent 
Investigator Report 
Changes since baseline assessment 
• 
Medical conditions 
• 
Pain Medications 
• 
Medical interventions/Adverse Events 
Medical 
Record/Patient Report 
Pregnancy Test 
Medical Record 
Pain Assessment 
Subject Report 

 
  
 
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Table 2 
Pre-Surgery (Intake) Assessment 
 
Type of Information 
Data Sources 
Pain Medications 
Subject Report 
15. PROCEDURE PROTOCOL 
The device is used in accordance with the instructions for use.  An initial target pneumoperitoneal pressure 
setting of 10mmHg will be used for the procedure.  At the discretion of the surgeon investigator, pressure will 
be adjusted as needed to accomplish the surgical procedure.  A standard insufflator with 3mm ports and one 5 
mm ports will be used for the procedure.    
Table 3 
Intraoperative/Procedure Information 
Type of Information 
Time Point 
Data Sources 
Date of Procedure 
Before opening 
Patient Medical 
Record 
Pneumoperitoneum pressure after 
camera trocar is inserted 
Intraoperative 
Investigator Report 
Increase in pressure and reason for 
change 
Intraoperative 
Investigator Report 
Adverse Events 
Intraoperative 
Investigator Report 
Unplanned concomitant 
interventions or procedures 
Intraoperative 
Investigator Report 
End tidal volume of CO2 (etCO2), 
recorded at the beginning and end 
of the procedure. 
Intraoperative 
Investigator Report 
Number of CO2 liters consumed 
At completion of the 
procedure 
Investigator Report 
Surgeon Survey on Quality of 
Visualization and Smoke 
Management 
Immediately Post-
operative 
Investigator Report 
Ultravision device(s) used (lot# and 
model #) 
Immediately Post-
operative 
Investigator Report 
Diathermy device(s) used 
Immediately Post-
operative 
Investigator Report 
Device Malfunction – recorded as 
an adverse event 
Intraoperative 
Investigator Report 
Number of Endometriosis Lesions 
Resected 
Post-operative  
Operative Report / 
Investigator Report 
Pain Assessment 
Just Prior to discharge 
Medical Record 

 
  
 
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Table 3 
Intraoperative/Procedure Information 
Type of Information 
Time Point 
Data Sources 
Pain Medications 
Prescribed at discharge 
Medical Record 
16. SURGEON SURVEY 
Immediately post procedure the investigator will be asked to provide feedback regarding visibility and 
smoke management during the procedure.  Responses will be recorded on a VAS scale. 
1. Overall quality of visualization. 
2. How often was smoke management a negative factor during the procedure. 
17. POST PROCEDURE FOLLOW-UP PROTOCOL 
16.1 Post-operative days 1-7:   
Subjects will be asked to complete a daily diary/self-assessment of pain.  The assessment will include a 
pain rating, location of pain and medications taken for pain.  The diary/self-assessment is included as a 
separate document.  
16.2 Post-operative 2 week (± 3 days) follow up visit: 
A 2 week follow up visit is current standard of care.  At this visit, adverse events will be assessed. A final 
pain assessment will be administered during this visit.   
16.3 Post-operative 4 week (± 1 week) follow up phone call: 
Patient satisfaction with cosmesis (scar appearance) after the surgery will be collected by means of a 
telephone follow-up where a simple cosmesis satisfaction survey will be administered by a study team 
member.7 
16.5 Unscheduled visit:  
 
 
7 Steinemann D, Raptis D, Lurje, Oberkofler C, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien P, 
Breitenstein S, Cosmesis and body image after single-[prt laparoscopic or conventional laparoscopic 
cholecystectomy: a multicenter double blinded randomized controlled trial (SPOCC-trial), BMC Surg. 2011; 
11:24, September 2011. 

 
  
 
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A pain assessment and adverse event assessment will be performed at any unscheduled visit.   
Additional evaluations will be completed at the discretion of the Principal Investigator based on the 
subject’s presenting complaint. 
18. ADVERSE EVENTS 
18.1. 
ADVERSE EVENT CATEGORIES 
For purposes of this protocol the adverse event definitions are derived from GCP standards and FDA 
Guidance.8   
Table 4 
Adverse Event Definitions 
Adverse Event 
(AE) 
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 medical device. Includes events related to the study device or 
comparator device, or the procedures involved. 
Serious Adverse 
Event 
(SAE) 
Adverse event that: 
 
▪ 
Led to death 
▪ 
Led to serious deterioration in the health of the subject, that: 
o 
Resulted in a life-threatening illness or injury, or 
o 
Resulted in a permanent impairment of a body structure or a body 
function, or 
o 
Required in-patient hospitalization or prolongation of existing 
hospitalization, or 
o 
Resulted in medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or a body 
function 
o 
Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect 
 
Planned hospitalization for a pre-existing condition without serious deterioration in 
health, is not considered a serious adverse event.  Hospitalization is defined as an 
admission greater than 24 hours 
 
Adverse Device 
Effect 
(ADE) 
Untoward and unintended response to a medical device or as a consequence of 
inadequate labeling and includes any event that is a result of user error.   
Serious Adverse 
Device Effect 
(SADE) 
Untoward medical occurrence that happens in a subject or other person, is related to the 
study device, comparator, or procedure, and is serious, but is not unanticipated  
 
 
8 Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirements. ISO 14155-1. 
International Organization for Standardization. 2011. 

 
  
 
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Unanticipated 
Serious Adverse 
Device Effect 
(USADE) 
Any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, procedure, or comparator device if that incidence 
effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the risk analysis report of the  plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
The signs, symptoms, and sequelae of an underlying adverse event (linked pathophysiologically to the 
AE) should not be reported as separate adverse events.      
All adverse events, of any type, are to be recorded on an “Adverse Event Form”.  Adverse events are to 
be characterized by their severity, relatedness the surgical procedure, need for therapy, and resolution 
status. 
Adverse events will initially be characterized as “serious” or “non-serious” by the study investigator.   
18.2. 
ADVERSE EVENT ADJUDICATION 
Events are to be initially judged by the investigator as to their relatedness to the study device, surgical 
procedure, or “other etiology”.  The classifications will be “not related”, “probably not related”, 
“undetermined”, “probably related”, or “related”.   
18.3. 
   REPORTING OF ADVERSE EVENTS AND UNANTICIPATED PROBLEMS 
Serious adverse events and Unanticipated Problems related to the research will be reported to the Mercy 
Institutional Review Board.  
18.4. 
SUBSEQUENT SURGICAL INTERVENTIONS 
Some complications may lead to a subsequent surgical intervention.  The reason for each subsequent 
surgical intervention and the action taken is recorded on the case report form, along with the identification 
of the type subsequent surgical interventions accordingly.  The exact type of intervention must be 
specified. 
19. PATIENT WITHDRAWAL 
A patient may choose to withdraw from participation in the study at any time without penalty.  If a patient 
chooses to withdraw, they will still receive medical care consistent with the standard of care.  The investigator 
may at their discretion withdraw a patient from participation or where intraoperative exclusions (defined in 
the I/E criteria) occur. Other examples include if the procedure necessitates conversion from laparoscopic to 
open technique, lack of adherence to visit schedule, adverse events, or safety concerns. For all withdrawals 
the date, point in the study, and reason for withdrawal will be recorded.  Patients that withdraw prior to the 
procedure or are withdrawn from the study due to an intraoperative exclusion are replaced.  
  

 
  
 
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20. STUDY SUSPENSION/TERMINATION 
If for any reason the principle investigator chooses to suspend or terminate the study, the IRB shall be 
informed of the decision and the basis of the decision.   
21. STUDY MATERIALS 
The Investigator is responsible for assuring that routine medical supplies, equipment, personnel, and facilities 
are available to successfully implement this study plan in a timely and efficient manner.  Provisions should be 
made for research and medical staff to sufficiently accomplish: 
▪ 
Screening of subjects to identify suitable study subjects, 
▪ 
Conducting and obtaining informed consent, 
▪ 
Scheduling for examinations and procedures, 
▪ 
Coordination, monitoring, and source data verification, 
▪ 
Case Report Forms, 
▪ 
Investigational devices and 
▪ 
Clinical study Plan and supporting study documentation. 
22.  PROVISION AND INVENTORY OF STUDY DEVICES 
The device and required materials will be provided to the Investigator by Alesi Surgical Ltd. 
23. DATA COLLECTION AND MANAGEMENT 
The investigator and study team members as delegated are responsible for collecting the data from the study. 
Copies of all imaging documentation files will be collected and retained by the study team. 
Case Report Forms (CRF) specifically created for this study will be used to collect all data. Case Report 
Forms shall reflect the contents of this study plan.  The CRF and any amendment to it shall bear a version 
number and each page shall be identifiable by the number and identification of the subject whose data the 
CRF pertains. If/when it is necessary to amend the CRFs, the Investigator shall review the study protocol to 
determine if an amendment to this study protocol is necessary.  All study protocol amendments require IRB 
notification.  If the amendments are significant changes in the study design IRB review and approval may be 
required.  The Investigator will work with the IRB for all changes to ensure the proper process for 
implementation of change occurs. 
Manually entered information on any paper study documents must be legibly written in black ink only.  If 
changes are required, a single line must be drawn through the incorrect information, the correct information 
written in, and the changes initialed and dated.  The reason for the correction should be noted, unless obvious. 

 
  
 
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Use of white-out, obscuring incorrect data (scribbling-out), and additional comments written on the 
documents is prohibited.  
The investigator must review sign and date each CRF or document review on a CRF review log; these 
responsibilities cannot be delegated to another person.  The investigator is responsible for the accuracy and 
completeness of all study data. 
All original imaging, laboratory, and procedural reports, etc., are considered source documents and will also 
be retained at the investigational site.  
Study subjects will be identified by unique study identification numbers.  The identification number is the 3-
digit study number.  A master key will contain the study identification number and patient identifier (as 
defined by the Study number, the patient ID number and the patient’s initials). The master key will be stored 
in the study binder and kept in a secure, locked location in the Principal Investigator’s office. 
Study binders containing study data (including subject pain diaries) will be collected and stored in a secure, 
locked location in the Principal Investigator’s office. Access to the records will be limited to the Lead Study 
Coordinator and the Principal Investigator only. 
For analysis data may be extracted from case report forms and entered into Excel spreadsheets by a member 
of the study team. The spreadsheet(s) containing the study data set will not contain protected health 
information.  Subjects will be identified by the 3-digit study number only (no initials).  The study data set will 
be stored on a study team member’s password-protected Mercy computer on a secure Mercy server.   
Study data will not be removed from the site listed above at any time during the course of this study.  Data 
extracted into spreadsheets may be shared outside of the facility for data analysis purposes.  All shared data 
will be de-identified. 
All public reporting of the results of this study will eliminate identifiable references to the subjects. 
24. IMAGING DIAGNOSTICS 
Any imaging performed for patients is considered consistent with standard of care. 
25. DATA ANALYSIS PLAN   
25.1. 
 SAMPLE SIZE JUSTIFICATION 
Ultravision is already cleared by the FDA for use in laparoscopic endometriosis.  This  post-market study 
is intended to evaluate user satisfaction and the relative impact the Ultravision™ System has on the 
procedure as opposed to demonstrating safety and efficacy.  The sample size selected (20) is considered 
to be a sufficient quantity to establish whether or not low impact surgery is facilitated with the use of the 

 
  
 
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Ultravision™ System.  This is designed as a single arm study to demonstrate feasibility of device use 
under low impact laparoscopy.  The Ultravision will either enable the procedure to be completed as 
planned or not, therefore a control arm is not considered necessary to make this determination. In 
addition, incorporating a control arm using the same conditions without the use of Ultravision may not be 
in the best interest of the patient. The study design is considered to appropriate for the research question 
that is being posed. 
25.2. 
DATA ANALYSIS 
Data collected will be summarized using descriptive statistics.   Results from other studies conducted by 
Alesi as well as clinical data gleaned from the medical literature will be used to assess the relative 
significance of the study results.  Additional exploratory analysis may be conducted during data analysis. 
26. TRAINING PROCEDURES 
The Principal Investigator in the study is a current Ultravision user, no additional device training is required.  
To ensure compliance with the study plan and regulatory requirements as well as accurate data collection, site 
training will include a detailed review of this Investigational Plan, case report form (CRF) completion 
instructions, adverse event reporting, device handling and inventory, monitoring logistics, and regulatory 
requirements.  
27.  ADMINISTRATION 
This study is being conducted as an “Investigator Sponsored” post-market study.  The Principal Investigator 
holds ultimate responsibility for the design, conduct, analysis, and reporting of the results from this study and 
is the primary contact for all matters related to this investigational plan.  The Principal Investigator is also 
accountable for monitoring this investigation and performing those actions necessary to protect the scientific 
credibility of the way this study is conducted.    
28. REGULATORY COMPLIANCE 
The Principal Investigator is responsible for ensuring that the study is implemented at their site according to 
the Investigator Agreement, this protocol, applicable laws, regulations, and any conditions of approval by 
either the respective Institutional Review Board.  The Principal Investigator is also responsible for ensuring 
that this study is conducted in a scientifically credible and ethical manner.  The Principal Investigator is 
responsible for the selection, training, and supervision of site-specific research personnel.  The Principal 
Investigator shall always perform responsibilities in a manner which protects the rights, safety, and well-being 
of subjects.    

 
  
 
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The Principal Investigator and all research staff participating in this investigation are expected to adhere to 
this investigational plan, Good Clinical Practices, applicable privacy laws, the Declaration of Helsinki, and 
any approval requirements imposed by an Institutional Review Board. The study will be submitted for review 
and approval by the Mercy Institutional Review Board.   
28.1. 
INSTITUTIONAL REVIEW BOARD 
Subjects may not be enrolled into this study until legal authority to do so has been granted by the  
authorizing Institutional Review Board.  A copy of all approval letters must be maintained in the site file. 
28.2. 
GOOD CLINICAL PRACTICES 
The principles of Good Clinical Practices defined in ISO 14155:2011-1 Clinical investigation of medical 
devices for human subjects – Part 1: General Requirements, Part 2: Clinical investigation plans will be 
adhered to in the design, conduct, analysis, and reporting of results of this investigation. 
29. PRIVACY AND CONFIDENTIALITY 
30. THIS STUDY IS TO BE PERFORMED IN ACCORDANCE WITH ALL APPLICABLE 
PRIVACY LAWS.  ALL DATA AND INFORMATION CONCERNING SUBJECTS AND THEIR 
PARTICIPATION IN THIS TRIAL ARE CONSIDERED CONFIDENTIAL.  ONLY 
AUTHORIZED INVESTIGATORS AND APPROVED STUDY PERSONNEL WILL HAVE 
ACCESS TO SOME PORTIONS OF THESE CONFIDENTIAL FILES.  INSTITUTIONAL 
REVIEW BOARDS AND OTHER REGULATORY AUTHORITIES ALSO HAVE THE RIGHT 
TO INSPECT AND COPY RECORDS PERTINENT TO THIS TRIAL.  RECORDS AND 
REPORTS 
The following records and reports must be created and/or maintained by the parties as specified below.   
30.1. 
INVESTIGATOR RECORDS 
Records to be maintained by the investigator in a designated study file include: 
▪ 
Site information 
o Site signature log  
o Responsibility log 
o Training and credentials of study personnel  
▪ 
Device information 

 
  
 
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o Ultravision and diathermy device inventory log including: date, quantity, lot numbers of 
all devices, identification of all persons the device was used on, and final disposition 
o Shipping documents 
▪ 
Clinical study Plan/Protocol 
o  Plan and all amendments 
▪ 
Institutional Review Boards Records 
o Institutional Review Board Membership List 
o Submission to Institutional Review Boards 
o Approval letters 
o Notification of unanticipated adverse device events 
o  updates/reports   
o Any other communication 
▪ 
Screening and enrollment form 
▪ 
Consent Form 
o Institutional Review Boards approved copy 
o Revised approved, consent forms  
▪ 
Case Report Forms (CRFs) 
o Annotated CRF and/or CRF instructions (if applicable) 
o Blank CRFs and completion instructions (if applicable) 
▪ 
Correspondence 
o All correspondence of material concern relating to the trial between the investigator and 
other parties (e.g. IRB).     
The following records must be maintained for each subject enrolled in the trial: 
▪ 
Signed Consent Form  
▪ 
Completed CRFs   
▪ 
Protocol Deviation Forms 

 
  
 
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▪ 
Complete medical records, including procedure reports, lab reports, professional notes, etc. for 
participating subjects. 
▪ 
Records pertaining to subject death during the investigation (including death records, death 
certificate, and autopsy report, if performed) 
30.2. 
INVESTIGATOR REPORTS 
Traditional Investigator Reports such as progress reports are not applicable due to the acute nature of the 
investigation.  The investigator shall be required to complete a summary report to Alesi Surgical, Ltd 
capturing their general observations. 
30.3. 
RECORD RETENTION 
Subject records, correspondence files, all supporting documentation, and reports must remain on file at 
the investigational site for a minimum of three years or in line with the Mercy’s document retention 
policy (if longer) after the completion/termination of this or when it is no longer needed to support a 
marketing application, whichever is later. 
31. RISK/BENEFIT ASSESSMENT   
Medical treatment provided to the patient is within the standard of care for this type of procedure.  Additional 
assessments for procedure data, end tidal CO2 measures, post procedure pain assessments, pain medication, 
cosmesis result, and adverse event information do not introduce new risks to the patient. If necessary, the 
investigator will increase the pressure required to achieve adequate visualization/working space. 
As surgical accessory devices, the Ultravision does not administer any medical treatment.  The risks 
associated with its use are consistent with other surgical accessories used in laparoscopic surgery.  The 
Ultravision™ System is required to undergo testing for sterility, biocompatibility, and electrical safety in 
order to demonstrate that such risks have been mitigated to acceptable levels. The benefits that are being 
evaluated in this study are quality of visualization under low impact laparoscopic conditions with the 
anticipated improvement in patient outcomes in terms of cosmesis and postoperative pain.  
32. RELATED DOCUMENTS   
The following documents are related to the proper execution of this protocol.  They include the following 
document types: 
A1.  Subject Informed Consent 
A2.  Case Report Forms 
A3.  Pain Assessments 
A4.  Instructions for Use Labeling 

 
  
 
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A5.  Recruitment Script 

 
  
 
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Study Data Collection Schedule 
 
Study Phase 
 
 
 
Data Collected 
Baseline & 
Enrollment 
Pre-
operative Procedure Discharge 
Pain  Diary 
Days 1-7 
Post-
Operative 
14 Day + 3 
days Post-
Operative 
Follow-up  
(clinic visit) 
4 ± 1 
week 
Telephone 
Survey 
Unscheduled 
visit 
Informed Consent 
X 
 
 
 
 
 
 
 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
 
 
 
Medicinal Allergies 
or Intolerance 
X 
 
 
 
 
 
 
 
Prior /Existing 
Medical Conditions 
X 
 
 
 
 
 
 
 
Prior/Existing 
Medical 
Interventions 
X 
 
 
 
 
 
 
 
Diagnosis (Indicating 
Surgical 
Intervention) 
X 
 
 
 
 
 
 
 
Current Drug 
Therapies and 
Reason 
X 
X 
 
 
 
 
 
 
Vital Signs 
X 
X 
 
 
 
 
 
 
Physical Exam 
X 
 
 
 
 
 
 
 
Additional 
Diagnostic Testing – 
Prescribed by 
Investigator 
X 
X 
 
 
 
 
 
 
X*** 
Pregnancy Test 
X 
X 
 
 
 
 
 
 
Procedure Data 
 
 
X 
 
 
 
 
 
User Assessments  
 
 
X 
 
 
 
 
 
Adverse Events 
 
X* 
X 
X 
  
X 
 
X 
Pain Medications 
 
X 
 
X** 
X 
X 
 
X 
Pain Assessment 
  
X 
 
X 
X 
X 
 
X 
Cosmesis Outcome 
 
 
 
 
 
 
X 
 
*Compared to baseline assessment (new adverse medical events that occurred since baseline assessment was 
conducted) 
**Denotes pain medication prescription given at discharge*** Additional evaluations will be completed at the 
discretion of the Principal Investigator based on the subject’s presenting complaint. 
 

 
  
 
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