Laparoscopic CholecystectomyNCT04162106
Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS
A study testing Smoke management during laparoscopic cholecystectomy using the Ultravision™ System and Smoke management during laparoscopic cholecystectomy using the Airseal® iFS in people with Laparoscopic Cholecystectomy, run by Alesi Surgical Ltd. at 1 site in United States.
Trial summary
This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Smoke management during laparoscopic cholecystectomy using the Ultravision™ System and Smoke management during laparoscopic cholecystectomy using the Airseal® iFS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2019to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18 years or older
- Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure
- Agrees to attend all follow-up assessments
- Is indicated for elective laparoscopic cholecystectomy
Who cannot join
- Existing comorbidities that would contraindicate them for laparoscopic surgery
- Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively
- Body Mass Index > 50
- Be pregnant (if female)
- Has a condition of unrelated chronic pain requiring medication
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Duke Regional Hospital
Durham, North Carolina, 27704
About this study
Official title: Open Label, Single Center, Randomized Study Evaluating the Feasibility of the Ultravision™ Visual Field Clearing System in Low Pressure Laparoscopic Cholecystectomy Compared To AirsealL® IFS
This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.
Read the detailed description
The primary hypothesis being tested in this study is that Ultravision facilitates the utilization of lower pneumoperitoneal pressures whilst maintaining an adequate visual field throughout the procedure with low demand for CO2 replenishment to maintain pneumoperitoneal pressure. 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 Airseal® iFS. Low pressure laparoscopy for this study is set at 10mmHg. This is a prospective, open-label, randomized controlled study. The study will include two study arms. Patients undergoing laparoscopic cholecystectomy will be randomized to either "Ultravision" (study arm 1) or Airseal® iFS (study arm 2). Both groups will conduct the procedure at 10mmHg, considered to be low pressure/low impact laparoscopic surgery. The study will enroll 30 patients, 15 per group. Both devices are being used according to their cleared label claims.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Smoke management during laparoscopic cholecystectomy using the Ultravision™ System, Smoke management during laparoscopic cholecystectomy using the Airseal® iFS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke management during laparoscopic cholecystectomy using the Ultravision™ SystemDevice
The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.
Smoke management during laparoscopic cholecystectomy using the Airseal® iFSDevice
The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.
| Study group | Role | What they receive |
|---|---|---|
| Ultravision™ System | Active comparator | Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System Receives: Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ System |
| Airseal® iFS | Active comparator | Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS Receives: Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Dioxide Utilization
The volume measured in Liters of Carbon Dioxide consumed during the procedure
Measured: Measured from Veress needle insertion to just prior to gall bladder removal
Quality of Visualization
The quality of visualization in the laparoscopic field
Measured: Measured from camera insertion through removal
Secondary outcomes (10)
Procedure time for Diathermy use
Measures the procedure time in minutes where diathermy is used
Measured: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Diathermy Power Setting
Highest diathermy setting used during the procedure
Measured: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Procedure Time
Overall procedure time in minutes
Measured: Measured from the insertion of the camera to the time of closure
End tidal CO2 Volume
End tidal volume of CO2
Measured: Measured at Veress needle insertion and just prior to gall bladder removal
Laparoscope cleaning
The number of times during the procedure that the laparoscope must be removed for cleaning to maintain visual field
Measured: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Pneumoperitoneum Pressure
The pneumoperitoneum pressure during the procedure and record of any increase beyond 10mmHg for visualization
Measured: Starting pneumoperitoneum pressure at the time of camera trocar insertion, record the maximum pressure that occurred during the procedure
Trocar Venting
The number of times the trocar is used to vent during the procedure for visualization
Measured: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Case Complexity
Case complexity compared to surgeon experience. Recorded as simple or routine or complex/difficult.
Measured: Immediately post-procedure
Pain Assessment
Pre and Post operative pain surveys
Measured: Pre-procedure and 1 to 7 days post procedure
Pain Medications
Amount and type of pain medication administered and record of use following the procedure
Measured: 1 to 7 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alesi Surgical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162106
- Sponsor's protocol ID
- Pro00103233
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Center, Randomized Study Evaluating the Feasibility of the Ultravision™ Visual Field Clearing System in Low Pressure Laparoscopic Cholecystectomy Compared To AirsealL® IFS
- ClinicalTrials.gov ID
- NCT04162106
- Acronym / sponsor ID
- Pro00103233
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alesi Surgical Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.
Detailed description
The primary hypothesis being tested in this study is that Ultravision facilitates the utilization of lower pneumoperitoneal pressures whilst maintaining an adequate visual field throughout the procedure with low demand for CO2 replenishment to maintain pneumoperitoneal pressure. 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 Airseal® iFS. Low pressure laparoscopy for this study is set at 10mmHg. This is a prospective, open-label, randomized controlled study. The study will include two study arms. Patients undergoing laparoscopic cholecystectomy will be randomized to either "Ultravision" (study arm 1) or Airseal® iFS (study arm 2). Both groups will conduct the procedure at 10mmHg, considered to be low pressure/low impact laparoscopic surgery. The study will enroll 30 patients, 15 per group. Both devices are being used according to their cleared label claims.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultravision™ System | Active comparator | Device: Smoke management during laparoscopic cholecystectomy using the Ultravision™ SystemSmoke management during laparoscopic cholecystectomy performed with the Ultravision™ System |
| Airseal® iFS | Active comparator | Device: Smoke management during laparoscopic cholecystectomy using the Airseal® iFSSmoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is 18 years or older
- Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure
- Agrees to attend all follow-up assessments
- Is indicated for elective laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- Existing comorbidities that would contraindicate them for laparoscopic surgery
- Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively
- Body Mass Index > 50
- Be pregnant (if female)
- Has a condition of unrelated chronic pain requiring medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoke management during laparoscopic cholecystectomy using the Ultravision™ SystemThe Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy. | Device | Ultravision™ System |
| Smoke management during laparoscopic cholecystectomy using the Airseal® iFSThe Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy. | Device | Airseal® iFS |
Primary outcome
Carbon Dioxide Utilization
Time frame: Measured from Veress needle insertion to just prior to gall bladder removal
The volume measured in Liters of Carbon Dioxide consumed during the procedure
Quality of Visualization
Time frame: Measured from camera insertion through removal
The quality of visualization in the laparoscopic field
10 secondary outcomes
Procedure time for Diathermy use
Time frame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Diathermy Power Setting
Time frame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Procedure Time
Time frame: Measured from the insertion of the camera to the time of closure
End tidal CO2 Volume
Time frame: Measured at Veress needle insertion and just prior to gall bladder removal
Laparoscope cleaning
Time frame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Pneumoperitoneum Pressure
Time frame: Starting pneumoperitoneum pressure at the time of camera trocar insertion, record the maximum pressure that occurred during the procedure
Trocar Venting
Time frame: Measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Case Complexity
Time frame: Immediately post-procedure
Pain Assessment
Time frame: Pre-procedure and 1 to 7 days post procedure
Pain Medications
Time frame: 1 to 7 days post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoke management during laparoscopic cholecystectomy using the Ultravision™ System and Smoke management during laparoscopic cholecystectomy using the Airseal® iFS in people with Laparoscopic Cholecystectomy, run by Alesi Surgical Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin S Yoo, MD (919-470-7038, sean.greene@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon Dioxide Utilization (time frame: Measured from Veress needle insertion to just prior to gall bladder removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.