A Randomized, Controlled Study Evaluating The Effectiveness Of The Ultravision Visual Field Clearing System in Laparoscopic Hysterectomy and Myomectomy
Phase: NA
Conditions: Pain, Hysterectomy, Myomectomy
Sponsor: Mercy Research

 
A RANDOMIZED, CONTROLLED STUDY EVALUATING THE EFFECTIVENESS OF THE 
ULTRAVISION™ VISUAL FIELD CLEARING SYSTEM IN LAPAROSCOPIC HYSTERECTOMY 
AND MYOMECTOMY
PROTOCOL NO.  18-091
PROTOCOL VERSION:  B
PROTOCOL VERSION DATE:  
NCT NUMBER:  03634306
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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CLINICAL TRIAL SUMMARY.................................................................................5
1.
Study Protocol Introduction & Background....................................................10
2.
Study Purpose.................................................................................................10
3.
Intended Use (Per Instructions for use)...........................................................10
4.
Device Description.........................................................................................10
5.
US Regulatory Status......................................................................................13
6.
Study Design..................................................................................................13
7.
Study Size.......................................................................................................13
8.
Duration..........................................................................................................13
9.
Hypotheses.....................................................................................................13
10.
Study Endpoints..............................................................................................14
10.1.
Primary Endpoints......................................................................................14
10.2.
Secondary Endpoints..................................................................................15
10.3.
Other Data Collection.................................................................................15
11.
Subject Identification & Selection..................................................................15
11.1.
INCLUSION CRITERIA...........................................................................16
11.2.
Exclusion Criteria.......................................................................................16
12.
Subject Informed Consent..............................................................................16
13.
Screening & Enrollment.................................................................................17
13.1.
Randomization and Blinding......................................................................18
13.2.
Preoperative Protocol.................................................................................18
13.3.
Procedure Protocol.....................................................................................19
14.
Surgeon Visualization Survey.........................................................................21
15.
Post Procedure Follow-up Protocol................................................................22
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16.
Adverse Events...............................................................................................23
16.1.
Adverse Event Categories...........................................................................23
16.2.
Adverse Event Adjudication.......................................................................24
16.3.
REPORTING OF ADVERSE EVENTS AND UNANTICIPATED PROBLEMS
24
16.4.
Subsequent Surgical Interventions..............................................................24
17.
Patient Withdrawal.........................................................................................24
18.
Study Suspension/Termination.......................................................................24
19.
Study Materials...............................................................................................24
20.
Provision and Inventory of Study Devices......................................................25
21.
Data Collection and Management...................................................................25
22.
Imaging Diagnostics.......................................................................................26
23.
Data Analysis Plan..........................................................................................26
23.1.
Sample Size Justification............................................................................26
23.2.
Data Analysis..............................................................................................26
24.
Training Procedures........................................................................................26
25.
Administration................................................................................................27
26.
Regulatory Compliance..................................................................................27
26.1.
Institutional Review Board.........................................................................27
26.2.
Good Clinical Practices..............................................................................27
27.
Privacy and Confidentiality............................................................................27
28.
Records and Reports.......................................................................................27
28.1.
Investigator Records...................................................................................28
28.2.
Investigator Reports....................................................................................29
28.3.
Record Retention........................................................................................29
29.
Risk/Benefit Assessment.................................................................................29
30.
Related Documents.........................................................................................30
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Compliance Statement
This study will be conducted in full accordance with this protocol, all applicable Mercy Research and Mercy 
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.  
Principal Investigator:  David Levine, MD 
(Electronic signature to be provided in IRBNet)
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CLINICAL TRIAL SUMMARY
Background
The smoke generated by electrosurgical devices in the process of dissection of tissues during laparoscopy can 
obscure the surgical visual field. Laparoscopic hysterectomy and laparoscopic myomectomy are procedures 
that produce a considerable amount of smoke, which impedes 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 electrostatic-precipitation of laparoscopic smoke is a new technique, marketed under the name 
Ultravision©, making it possible to precipitate the smoke as it is created, thereby actively eliminating it from 
the field of view. 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 (ref: Ansell J. Surg, 
Endosc. (2014) 28: 2057-2065) showed that electrostatic-precipitation significantly improved visibility 
(reduction of visual impairment) and reduced surgery time in laparoscopic cholecystectomy.
Ultravision is cleared for use in all laparoscopic surgery i.e. including laparoscopic hysterectomy and 
myomectomy, in the United States.  However, the clinical benefits arising from its use in gynaecology have 
not yet been quantitatively assessed and published in an independent medical journal.
Study Purpose: 
There are three main study objectives
1.
To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and 
myomectomy on the quality of visualization in the laparoscopic field
2.
To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and 
myomectomy on procedural characteristics
3.
To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and 
myomectomy on clinical outcomes
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Primary Hypothesis
The primary hypothesis being tested in this study is that using Ultravision during laparoscopic hysterectomy 
and myomectomy improves visualization similar to that reported when used in laparoscopic cholecystectomy 
without the need for CO2 exchange and that, by doing so, the amount of CO2 that is utilized during the 
procedure and that the patient is exposed to is reduced compared to the current standard of care.  Ultravision 
has already been shown in laparoscopic cholecystectomy to minimize the amount of CO2 that a patient is 
exposed to during laparoscopic surgery because it does not rely on the process of dilution using ongoing CO2 
supply from the insufflator.  
Secondary hypothesis:
There are two aspects to CO2 exposure during laparoscopic surgery: the amount of gas used and the intra-
abdominal pressure of the pneumoperitoneum. In addition to the amount of CO2 utilized during the procedure 
another related factor is the intra-abdominal pressure of the pneumoperitoneum.  Decreasing the intra-
abdominal pressure below the conventional 12-15 mmHg during laparoscopic surgery has been shown by 
others to lead to improved clinical outcomes.1
Use of the Ultravision during laparoscopic hysterectomy and myomectomy is expected to allow for lower 
intrabdominal insufflation pressures. In this study, the target abdominal pressure for all procedures conducted 
will be 10mmHg.  The ability to maintain that pressure during the procedure will be reported and compared 
for the randomized group.  In addition to this secondary endpoint other procedure data will be collected to 
assess the potential impact of the Ultravision™ System on procedure characteristics such as adverse events, 
procedure time, patient temperature, patient end tidal CO2 level, post-op medications for pain etc.
Study Population
The study will enroll female patients who are indicated for laparoscopic hysterectomy or myomectomy.  
Patients must meet all inclusion/exclusion criteria.
Study Design
This is a prospective blinded, randomized controlled study.  The study will include three study arms: 
1
 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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Patients undergoing laparoscopic hysterectomies will be randomized to one of either “Ultravision” (study arm 
1) or “no Ultravision” (study arm 2, i.e. the current standard of care) groups.  The study will be conducted 
blinded to the investigator during the procedure through patient discharge.  The Ultravision system will be 
present in both, with the generator covered (not seen by user) and either on or off depending on the 
randomization. 30 patients will be enrolled, 15 per group.
Whilst less common, it has been reported that myomectomy is considered to be a procedure that generates a 
great deal of surgical smoke.  Five patients undergoing myomectomy will have their procedures conducted 
using the Ultravision (study Arm 3).  Results from this study arm will be reported and discussed.  All 
measures conducted for the randomized study arms will be collected but no comparative statistical analysis is 
planned for this group.
Primary Endpoints
Success will be based on demonstration that the procedures using Ultravision demonstrate a meaningful 
difference/improvement when compared to the control according to the following measures:
1.
The quality of visualization in the laparoscopic field of view will be assessed by the investigator 
using a 5 point Visual Analog Scale (VAS).  Results for the laparoscopic hysterectomy will be 
compared to determine if there is a significant difference between “Ultravision” and “no Ultravision” 
groups.
2.
The amount of Carbon Dioxide (CO2) utilization during the procedure will be measured.  Results for 
the laparoscopic hysterectomy study arms will be compared to determine if there is a significant 
difference in the amount of CO2 utilized between groups.
Secondary Endpoints:
The following data will be collected for all groups.  Comparisons between the study arms 1 and 2 will be 
conducted.  For study arm 3 the data will be reported and generally compared to study arms 1 and 2.

From the initial 10mmHg setpoint, the time in minutes until a change /increase in the abdominal 
pressure is required, and the reason for the change (i.e. visualization, access).

The number of times the laparoscope is removed in order to clean it of debris.

The number of times a trocar valve is opened to evacuate smoke.

The number of pauses due to a loss of sufficient visibility.

The number of times there is a loss of pneumoperitoneum due to the evacuation of the surgical 
smoke.

The maximum intra-abdominal pressure used and the duration at that pressure.

The number of times intra-abdominal pressure required adjustment during the procedure.
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
The patient's temperature during the procedure.

The amount of pain control medicine administered to the patient prior to discharge from the hospital 
and reported at the two week follow-up visit.

Adverse Events.

 End tidal CO2 volume throughout the procedure (taken at 15-minute intervals)

Duration of the procedure (from the time all ports are in place to completion of the colpotomy for  
hysterectomy and to closure of last uterine defect for myomectomy).

Duration of post-operative hospital care (time of entry to post-operative recovery to discharge)
Pain assessments (including pain score and pain location) documented during post-operative recovery, prior to 
discharge and at the two week follow up visit. Other Data Collection:
Electrosurgical instrument(s) used.
Study Size:
30 consecutive patients undergoing laparoscopic hysterectomy randomized 1:1 to either an “Ultravision” or 
“No Ultravision” (control, current standard of care) group.  Five consecutive patients undergoing 
myomectomy.
Duration of Study:
Each patient will be assessed from the start of procedure until discharge from the hospital.  Routine follow-up 
(i.e. that normally undertaken under current standard of care) will be performed.  Formal follow-up for the 
study is through patient discharge, however any adverse events that occur thereafter that are related to the 
procedure will be reported.
The target for the overall duration of the study is six months.
Data Analysis:  Descriptive and comparative statistics for all endpoints will be applied to analyze the results 
from study arms 1 and 2.  Success is dependent on a favorable comparison between Ultravision and no 
Ultravision groups for Primary Endpoints. 95% confidence levels are assigned.  Descriptive statistics for 
study arm 3 with general comparisons to study arms 1 and 2.  Exploratory analysis may be conducted.
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1.
STUDY PROTOCOL INTRODUCTION & BACKGROUND 
The Ultravision™ System is a 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 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.  
This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when 
compared to the current standard of care (no field clearing/evacuation).  Comparisons in terms of surgical 
field visualization, procedure times, and CO2 consumption will be conducted in order to determine whether 
or not any clinical benefits are derived from the use of the Ultravision™ System compared to the standard of 
care.  In order to reduce bias, the study is being conducted using a randomized blinded design.
2.
STUDY PURPOSE 
There are three main study objectives
1.
To evaluate the impact of use of Ultravision™ System during laparoscopic hysterectomy and 
myomectomy on the quality of visualization in the laparoscopic field;
2.
To evaluate the impact of use of Ultravision™ System during laparoscopic hysterectomy and 
myomectomy on procedural characteristics; and
3.
To evaluate the impact of use of Ultravision™ System during laparoscopic hysterectomy and 
myomectomy on clinical outcomes.
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 
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the effect of the Ultravision™ System during use to improve the visualization of the field of view is 
demonstrated in Figures 2 and 3 below:
Figure 1 View before and during cutting with an electrosurgical instrument
 
Figure 2 Electrosurgical smoke without Ultravision Figure 3 Electrosurgical smoke cleared with Ultravision
The system includes the following elements:
Standalone battery-operated generator unit 
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Figure 4 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.    
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Figure 5 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 
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 blinded, randomized controlled study.
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Arms 1 and 2: Patients enrolling in study arms 1 and 2 who are undergoing laparoscopic hysterectomy will be 
randomized to either the Ultravision™ System (Arm 1) or Standard of Care/no Ultravision (Arm 2) study 
arms.  
Arm 3:  Patients enrolling in study arm 3 who are undergoing a laparoscopic myomectomy will have their 
procedure conducted with the Ultravision™ System.  The procedure is purported to generate the greatest 
smoke and therefore constitutes a worst-case challenge for the system.
All prescribed evaluations will be performed for all study arms.
7.
STUDY SIZE
Arms 1 and 2 (randomized) will enroll 15 patients each.  Arm 3 will enroll an additional 5 patients.
8.
 DURATION
The total duration of the study is expected to be approximately 6 months.
9.
HYPOTHESES
Primary hypothesis:
The primary hypothesis being tested in this study is that using the Ultravision™ System during laparoscopic 
hysterectomy and myomectomy improves visualization similar to that reported when used in laparoscopic 
cholecystectomy and that the amount of carbon dioxide (CO2) utilized is reduced as CO2 is deemed related to 
complications such as tissue desiccation and postoperative pain.2 
Secondary hypothesis:
In addition to the amount of CO2 utilized during the procedure another related factor is the intra-abdominal 
pressure of the pneumoperitoneum.  Decreasing the intra-abdominal pressure below the conventional 12-15 
mmHg during laparoscopic surgery has been shown by others to lead to improved clinical outcomes.3
2
 Veekash G, Wei LX, Su M, Carbon dioxide pneumoperitoneum, physiologic changes and anesthetic 
concerns, Ambulatory Surgery, 162 July 2010.
3
 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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Use of the Ultravision during laparoscopic hysterectomy and myomectomy is expected to allow for lower 
intrabdominal insufflation pressures. In this study, the target abdominal pressure for all procedures conducted 
will be 10mmHg.  The ability to maintain that pressure during the procedure will be reported and compared 
for the randomized group.  In addition to this secondary endpoint other procedure data will be collected to 
assess the potential impact of the Ultravision™ System on procedure characteristics such as adverse events, 
procedure time, patient temperature, patient end tidal CO2 level, post-op medications for pain etc.
10. STUDY ENDPOINTS
10.1.
PRIMARY ENDPOINTS
Success will be based on demonstration that the procedures using the Ultravision™ System show a 
meaningful difference/improvement when compared to the control according to the following measures:
1.
The quality of visualization in the laparoscopic field of view will be assessed by the investigator 
using a 5 point Visual Analog Scale (VAS).  Results for the laparoscopic hysterectomy will be 
compared to determine if there is a significant difference between Arm 1 (Ultravision) and Arm 2 (no 
Ultravision).
2.
The amount of Carbon Dioxide (CO2) utilized during the procedure will be monitored.  Results for 
the laparoscopic hysterectomy study arms (randomized cohort) will be compared to determine if there 
is a significant difference in the amount of CO2 utilized between groups.
10.2.
SECONDARY ENDPOINTS
The following data will be collected for all groups.  Comparisons between the study arms 1 and 2 will be 
conducted.  For study arm 3 the data will be reported and generally compared to study arms 1 and 2.

From the initial 10mmHg setpoint, the time in minutes until a change /increase in the 
abdominal pressure is required, and the reason for the change (i.e. visualization, access).

The number of times the laparoscope is removed in order to clean it of debris.

The number of times a trocar valve is opened to evacuate smoke.

The number of pauses due to a loss of sufficient visibility.

The number of times there is a loss of pneumoperitoneum due to the evacuation of the 
operating smoke.

The maximum intra-abdominal pressure used and the duration at that pressure.

The number of times intra-abdominal pressure required adjustment during the procedure

The patient's temperature during the procedure.
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
The amount of pain control medicine administered to the patient prior to discharge from 
the hospital and reported at the two week follow-up visit.

Adverse Events.

 End tidal CO2 volume (etCO2) throughout the procedure (15 minute intervals).

Duration of the procedure (from the time all ports are in place to completion of the 
colpotomy for hysterectomy and to closure of the last uterine defect for myomectomy).

Duration of post-operative hospital care (time of entry to post-operative recover to 
discharge).

Pain assessments (including pain score4 and pain location) documented during post-
operative recovery, prior to discharge and at the two week follow up visit. 
o
An attempt will be made to assess pain scores in different areas of the body, 
specifically abdominal pain and referred (“shoulder tip”) pain. 
10.3.
OTHER DATA COLLECTION
List of the electrosurgical instrument(s) used.
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 
4
 Dworkan et al, Core outcome measures for chronic pain clinical trials:IMMPACT recommendations, Pain 
113 (2005) 9–1
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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.  
11.1.INCLUSION CRITERIA
Subjects MUST meet all the following:
I1
Is 21 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 clinically indicated to undergo laparoscopic hysterectomy (with or without 
unilateral or bilateral oophorectomy or salpingo-oophorectomy) or 
myomectomy.
11.2.EXCLUSION CRITERIA
Subjects MUST not have any of the following:
E1
Existing comorbidities that would contraindicate them for laparoscopic surgery.
E2
Be pregnant.
12.  SUBJECT INFORMED CONSENT AND HIPAA AUTHORIZATION
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 criteria will undergo the 
informed consent process to authorize the gathering of data recorded on the Subject Screening & Enrollment 
Form.  
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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.
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.   Each patient will be assigned a unique study number.  Baseline information 
will be collected, consistent with the standard of care.
Table 1
Baseline Form Information
Type of Information
Data Sources
Time Frame
Date of Evaluation
Investigator
NA
Subject Age
Subject interview
NA
Ethnicity
Subject interview & medical record
NA
Medicinal allergies or intolerance
Subject interview & medical record
Within one month prior 
to surgery
Physical Exam  
Investigator Report
Within one month prior 
to surgery
Prior/Existing Medical Conditions
Subject interview & medical record
Within one month prior 
to surgery
Prior/Existing Medical 
Interventions
Subject interview & medical record
Within one month prior 
to surgery
Diagnosis indicating surgical 
intervention
Investigator Report
Within one month prior 
to surgery
Current Drug Therapies
Subject interview & medical record
Within one month prior 
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Table 1
Baseline Form Information
Type of Information
Data Sources
Time Frame
to surgery
Diagnostic Tests and Exams  
Abdominal ultrasound
Investigator Report
Within one month prior 
to surgery
Labs – as normally prescribed
Pregnancy test (if child-bearing 
age)
Hospital laboratory
Within 3 months prior to 
surgery
13.1.
RANDOMIZATION AND BLINDING
For study arms 1 and 2 patients will be randomized using a paper envelope system.  Randomization shall 
occur just prior to surgery.  The investigator will not be informed of the randomization assignment until 
after the surgical intervention for a patient is completed.  For randomization, a simple envelope system 
will be used.  Pre-made study arm assignment envelopes of the study quantity will be created.  30 
envelopes – 15 containing “Ultravision” cards and 15 containing “Non-Ultravision” cards - will be 
opened by the Lead Study Coordinator just prior to the procedure.  For patients randomized and 
withdrawn prior to the procedure or converted to open procedure, replacement envelopes will be added to 
the envelope pool.
To preserve blinding of the investigator/surgeon during the procedure, the Ultravision™ System 
consumable will be introduced into the patient and the generator will appear operational during all 
procedures.  The display will be covered during use so that the investigator is not aware of whether the 
system is on or off.  If for any reason unblinding occurs accidentally or the Principal Investigator deems it 
necessary to unblind a particular patient, it will be recorded by notifying the Lead Study Coordinator and 
recording the reason for this unblinding on the narrative CRF in the relevant section.  Study assessments 
will be collected per protocol, but the data will not be pooled with blinded data for analysis.  
13.2.
PREOPERATIVE PROTOCOL
 Patients will be assessed preoperatively in accordance with the current standard of care.
Table 2
Preoperative Assessments
Conducted within 24 hours of surgery
Type of Information
Collected within 24 hours of surgery
Data Sources
Patients general wellbeing (illness such as flu, cold etc.…)
Investigator Report
Changes since baseline assessment

Medical conditions

Drug therapy

Medical interventions
Medical 
Record/Patient 
Report
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Table 2
Preoperative Assessments
Conducted within 24 hours of surgery
Type of Information
Collected within 24 hours of surgery
Data Sources
Laboratory Panel – as normally prescribed
Pregnancy test (if child bearing age)
Medical Record
13.3.
PROCEDURE PROTOCOL
The Ultravision™ System will be set up in the OR for all cases.  For randomized study arms 1 and 2, the 
system will be covered such that the electronic display is not visible to the investigator.  The system will 
be turned off for all non-Ultravision procedures.  For all procedures, the Ionwand will be 
inserted/introduced as described in the Instructions for Use.  
Table 3
Intraoperative/Procedure Information
Type of Information
Time Point
Data Sources
Date of Procedure
Before opening
Patient Medical 
Record
Anesthesia
Before opening
Investigator Report
Procedure to be performed
Before opening
Investigator Report
Pneumoperitoneum pressure after 
camera trocar is inserted
Intraoperative
Investigator Report
The From the initial 10mmHg setpoint, 
the time in minutes to a change 
/increase in the abdominal pressure 
and the reason for the change i.e. 
visualization, access.
Intraoperative
Investigator Report
The maximum intra-abdominal 
pressure used and duration at that 
pressure, using a stop watch that is 
reset each time the pressure is 
increased.
Intraoperative
Investigator Report
The number of times intra-abdominal 
pressure required adjustment during 
the procedure
Intraoperative
Investigator Report
The number of pauses due to a loss of 
Intraoperative
Investigator Report
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Table 3
Intraoperative/Procedure Information
Type of Information
Time Point
Data Sources
sufficient visibility 
The number of times there is a loss of 
pneumoperitoneum due to the 
evacuation of the operating smoke
Intraoperative
Investigator Report
The number of times the laparoscope 
is removed in order to clean it of 
debris
Intraoperative
Investigator Report
The number of times a trocar valve is 
opened to evacuate smoke.
Intraoperative
Investigator Report
The patient's temperature at 15-minute 
intervals during the procedure.
Intraoperative
Investigator Report
Adverse Events
Intraoperative
Investigator Report
Planned concomitant interventions 
(bilateral or unilateral oophorectomy 
or salpingo-oophorectomy)
Intraoperative
Investigator Report
Unplanned concomitant interventions 
or procedures
NA
Investigator Report
End tidal volume of CO2 (etCO2), 
recorded at 15-minute intervals during 
the procedure
Intraoperative
Investigator Report
Number of CO2 liters consumed during 
the procedure
Intra-operative
Investigator Report
Overall procedure time* – 
NA
Investigator Report
Surgeon Survey on Quality of 
Visualization
Immediately Post-
operative
Investigator Report
Electrosurgical devices used
NA
Investigator Report
The amount of pain control medicine 
administered to the patient during 
recovery, prior to discharge from the 
hospital, and at 2-week follow-up
Post-operative
Investigator Report
The time from entry to post-operative 
recovery  to discharge 
Post-operative
Investigator Report
Pain Assessments (including pain 
score and pain location) documented 
during post-operative recovery and 
prior to discharge 
Post-Operative
Patient Report (0-10 
Numerical Rating  
Scale)
Pain Assessment at two week follow-
up visit 
2 week follow up visit
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Table 3
Intraoperative/Procedure Information
Type of Information
Time Point
Data Sources
Device used (lot# and model #)
NA
Investigator Report
Device malfunction
NA
Investigator Report
 * Overall procedure time is defined as the time from when all ports are in place to the time when 
colpotomy is performed for hysterectomy procedures or when the last uterine defect is closed for 
myomectomy procedures.
14.  SURGEON VISUALIZATION SURVEY
Immediately post procedure the investigator will be asked three questions:
1.
Proportion of operating time with effective visibility?
A 1-100 numerical rating scale will be used to estimate the time proportion.
2.
What is the overall rating of visibility?
The following scoring scheme will be applied:
Score
Impairment Scale
Impairments are:
Quality
1
Imperceptible
Excellent
2
Perceptible (but not interfering)
Good
3
Slightly interfering
Fair
4
Interfering
Poor
5
Highly interfering
Bad
3.
For randomized study arms do you know if the patient was in the Ultravision group?
A yes or no, or don’t know answer and the information that influenced the answer is recorded.
15. POST PROCEDURE FOLLOW-UP PROTOCOL
Post procedure follow-up assessments include discharge and 2-week follow-up, which is the current standard 
of care, as prescribed Attachment 4.   
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16. ADVERSE EVENTS
16.1.
ADVERSE EVENT CATEGORIES
For purposes of this protocol the adverse event definitions are derived from GCP standards and FDA 
Guidance.5  
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 
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.
5
 Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirements. ISO 14155-
1. International Organization for Standardization. 2011.
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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 implant procedure, need for therapy, and resolution 
status.
Adverse events will initially be characterized as “serious” or “non-serious” by the study investigator.  
16.2.
ADVERSE EVENT ADJUDICATION
Events are to be initially judged by the investigator as to their relatedness to the study device, implant 
procedure, or “other etiology”.  The classifications will be “not related”, “probably not related”, 
“undetermined”, “probably related”, or “related”.  
16.3.
   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. 
16.4.
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 according.  The exact type of intervention must be specified.
17. 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. 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.  
18. 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.  
19. 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:
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
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.
20.  PROVISION AND INVENTORY OF STUDY DEVICES
The device and required materials will be provided to the Investigator by Alesi Surgical Ltd.
21. 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 IP to determine if 
an amendment to this IP is necessary.
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. 
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. 
For analysis data may be extracted from case report forms and entered into spreadsheets or local 
computerized systems.
Study subjects will be identified by unique study identification numbers.  The identification number is the 3-
digit study number and the patients three initials.  A master key will contain the study identification number 
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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 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.
Study data will not be removed from the site listed above at any time during the course of this study.  Data 
extracted into spreadsheets or computer files may be shared outside of the facility for data analysis purposes.  
Such data extractions will be transmitted to the Biostatistician by the Mercy Secure File Transfer System for 
data analysis.  All shared data will be de-identified.
22. IMAGING DIAGNOSTICS
All imaging performed for patients is considered consistent with standard of care.
23. DATA ANALYSIS PLAN  
23.1.
 SAMPLE SIZE JUSTIFICATION
The sample size selected (15) per group is considered to be a number to allow for a meaningful 
comparison between the study arms conducted by a single investigator.  As a post-market study intended 
to evaluate user satisfaction and relative impact the Ultravision™ System has on the procedure as 
opposed to demonstrating safety and efficacy, the sample size is considered to be sufficient for that 
purpose.  This essential information is identified in the primary and secondary endpoints.     
23.2.
DATA ANALYSIS
Data collected will be summarized using descriptive statistics.  For study success results must 
demonstrate a clinical benefit for the randomized Ultravision group compared to the no Ultravision group 
based upon the primary endpoint analysis.  Additional exploratory analysis may be conducted during data 
analysis.  Because the study is not statistically powered, analysis for primary and secondary endpoints 
will be conducted using comparative statistics with the caveat understood regarding the relatively small 
sample sizes for each group.  
24. TRAINING PROCEDURES
Specific training of trial personnel is the responsibility of the Investigator.  Training will occur before the first 
device use.  To ensure compliance with the study plan and regulatory requirements as well as accurate data 
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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. 
25.  ADMINISTRATION
This study is being conducted as an “Investigator Sponsored” post-market study.  The 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 Primary 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.   
26. REGULATORY COMPLIANCE
The investigators 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.  
26.1.
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.
26.2.
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.
27. PRIVACY AND CONFIDENTIALITY
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.  All public reporting of the results of this study will eliminate identifiable references to 
the subjects.
28. RECORDS AND REPORTS
The following records and reports must be created and/or maintained by the parties as specified below.  
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28.1.
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
CVs of all study personnel
o
Training records for all study personnel

Clinical study Plan/Protocol
o
 plan and all amendments
o
Blank sets of each version of CRFs and Consent Forms

Institutional Review Boards Records
o
Institutional Review Board Membership List
o
Submission to Institutional Review Boards
o
Approval letters
o
Notification of serious and 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 

CRFs
o
Annotated CRF, CRF worksheets, and/or CRF instructions
o
Blank CRFs

Correspondence
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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

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)
28.2.
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.
28.3.
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 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.
29. RISK/BENEFIT ASSESSMENT  
As a surgical accessory device, the Ultravision™ System does not administer any medical treatment.  The 
risks associated with its use are consistent with other surgical accessories used in laparoscopic surgery.  The 
device has been tested for sterility, biocompatibility, and electrical safety demonstrating that such risks have 
been mitigated to acceptable levels. The benefits that are being evaluated in this study are improved 
visualization, lower pressure of pneumoperitoneum, and CO2 consumption have the potential to favorably 
impact patient outcomes. 
30. RELATED DOCUMENTS  
The following documents are related to the proper execution of this protocol.  They include the following 
document types:
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A1. Subject Informed Consent
A2. Case Report Forms
A3. Instructions for Use Labeling
A4. Study Visit Schedule
Study Phase
Baseline
Pre-
operative 
Visit
Procedure
Post 
Procedure 
– prior to 
discharge 
assessmen
t
Discharge 
Assessment
2-week Post-
discharge 
follow up
Visit Number 
Study Day
Procedures:
Informed Consent
X
Eligibility Criteria
X
Medications and 
Allergies
X
X
X
X
X
Medical Record Review
X
X
Vital Signs
X
X
Physical Exam
X
X
Lab Test
X
X
Pregnancy Test
X
X
Abdominal Ultrasound
X
Randomization
X
Procedure:
Laparoscopic 
Hysterectomy OR
Laparoscopic 
myomectomy
X
Visual Analog Scale
X
Adverse Event 
Assessment
X
X
X
X
Pain Assessment*
X
X
X
 
*Pain Assessments (including pain score and pain location) documented during post-operative recovery and 
prior to discharge will be recorded
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