Gynecologic DiseasesNCT02654808
AirSeal®Insufflation Trocar/CO2 Absorption Study
A study testing AirSeal trocar and Standard trocar in people with Gynecologic Diseases, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Diseases
- What is being tested?
- AirSeal trocar and Standard trocar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any woman ≥ 18 years of age undergoing a gynecologic laparoscopic procedure
- Able to understand the consenting process and willing to participate in study
Who cannot join
- Patient unable to undergo laparoscopic procedure due to size of pathology or medical comorbidities
- Emergent surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Comparison of CO2 Absorption During Gynecologic Laparoscopy Using the AirSeal® Valveless Trocar System Versus Standard Insufflation Trocars at Intra-abdominal Pressures of 10 mmHg and 15 mmHg - a Randomized Controlled Trial
The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg.
The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.
Read the detailed description
Three main factors affect patients' cardiopulmonary status during gynecologic laparoscopy: 1) degree of Trendelenburg tilt (25 - 30°), 2) carbon dioxide (CO2) absorption and 3) increased intra-abdominal pressure (10 -20 mmHg). Slight modifications to any or all of these three factors can lead to a significant decrease in morbidity.
The AirSeal® valveless trocar system reduces CO2 absorption when compared to standard trocars during renal laparoscopy. Also, use of this trocar system provides a more stable intra-abdominal pressure when compared to standard trocars, a feature that could possibly allow for laparoscopic surgery to be performed at lower intra-abdominal pressures.
- Conditions
- Gynecologic Diseases
- Being tested
- AirSeal trocar, Standard trocar
- Keywords
- Gynecology, Laparoscopy, Pneumoperitoneum, CO2 absorption
- Medical subject headings
- Genital Diseases, Female, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSeal trocarDevice
The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
Standard trocarDevice
A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
| Study group | Role | What they receive |
|---|---|---|
| Standard trocar/ IAP 15 mmHg | Active comparator | Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. Receives: Device: Standard trocar |
| Standard trocar/ IAP 10 mmHg | Active comparator | Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. Receives: Device: Standard trocar |
| AirSeal trocar/ IAP 15 mmHg | Active comparator | Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. Receives: Device: AirSeal trocar |
| AirSeal trocar/ IAP 10 mmHg | Active comparator | Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. Receives: Device: AirSeal trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg
This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases < 60 minutes, the CO2 absorption rate at 15 minutes will be used.
Measured: 15 minutes & 60 minutes from surgery start time
Secondary outcomes (4)
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy.
Measured: At the end of surgery (approximately 1 hour)
Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars
Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2).
Measured: At the end of surgery (approximately 1 hour)
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery.
Measured: 4 to 6 hours, and 12 to 23 hours following surgery
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg
This outcome is measured by calculating the CO2 elimination rate.
Measured: 15 minutes & 60 minutes from surgery start time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseasesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- SurgiQuest, Inc.
- Responsible party
- Sponsor
- Investigators
- Timothy Ryntz, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654808
- Sponsor's protocol ID
- AAAQ6474
- Status last verified
- Aug 2021
- First submitted
- 11 Jan 2016
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2.
PubMed 20888033Tan PL, Lee TL, Tweed WA. Carbon dioxide absorption and gas exchange during pelvic laparoscopy. Can J Anaesth. 1992 Sep;39(7):677-81. doi: 10.1007/BF03008229.
PubMed 1394755Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. doi: 10.1016/j.jclinane.2005.01.013.
PubMed 16517337Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5. doi: 10.1016/s0952-8180(01)00286-0.
PubMed 11498317CONMED - Transforming Laparosopic Surgery. Available at: http://www.conmed.com/en/hybrid-product-landing-pages/airseal. Retrieved January 12, 2018.
Wolf JS Jr, Monk TG, McDougall EM, McClennan BL, Clayman RV. The extraperitoneal approach and subcutaneous emphysema are associated with greater absorption of carbon dioxide during laparoscopic renal surgery. J Urol. 1995 Sep;154(3):959-63.
PubMed 7637101Ng CS, Gill IS, Sung GT, Whalley DG, Graham R, Schweizer D. Retroperitoneoscopic surgery is not associated with increased carbon dioxide absorption. J Urol. 1999 Oct;162(4):1268-72.
PubMed 10492177Motew M, Ivankovich AD, Bieniarz J, Albrecht RF, Zahed B, Scommegna A. Cardiovascular effects and acid-base and blood gas changes during laparoscopy. Am J Obstet Gynecol. 1973 Apr 1;115(7):1002-12. doi: 10.1016/0002-9378(73)90683-2. No abstract available.
PubMed 4266615Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012.
PubMed 19542853Sefr R, Puszkailer K, Jagos F. Randomized trial of different intraabdominal pressures and acid-base balance alterations during laparoscopic cholecystectomy. Surg Endosc. 2003 Jun;17(6):947-50. doi: 10.1007/s00464-002-9046-9. Epub 2003 Mar 14.
PubMed 12632130Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980.
PubMed 24686347Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
PubMed 26275545Park JS, Ahn EJ, Ko DD, Kang H, Shin HY, Baek CH, Jung YH, Woo YC, Kim JY, Koo GH. Effects of pneumoperitoneal pressure and position changes on respiratory mechanics during laparoscopic colectomy. Korean J Anesthesiol. 2012 Nov;63(5):419-24. doi: 10.4097/kjae.2012.63.5.419. Epub 2012 Nov 16.
PubMed 23198035Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
PubMed 17043939Kandil TS, El Hefnawy E. Shoulder pain following laparoscopic cholecystectomy: factors affecting the incidence and severity. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):677-82. doi: 10.1089/lap.2010.0112.
PubMed 20701547
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of CO2 Absorption During Gynecologic Laparoscopy Using the AirSeal® Valveless Trocar System Versus Standard Insufflation Trocars at Intra-abdominal Pressures of 10 mmHg and 15 mmHg - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02654808
- Acronym / sponsor ID
- AAAQ6474
- Conditions
- Gynecologic Diseases
- Keywords
- Gynecology, Laparoscopy, Pneumoperitoneum, CO2 absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- SurgiQuest, Inc.
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg.
The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.
Detailed description
Three main factors affect patients' cardiopulmonary status during gynecologic laparoscopy: 1) degree of Trendelenburg tilt (25 - 30°), 2) carbon dioxide (CO2) absorption and 3) increased intra-abdominal pressure (10 -20 mmHg). Slight modifications to any or all of these three factors can lead to a significant decrease in morbidity.
The AirSeal® valveless trocar system reduces CO2 absorption when compared to standard trocars during renal laparoscopy. Also, use of this trocar system provides a more stable intra-abdominal pressure when compared to standard trocars, a feature that could possibly allow for laparoscopic surgery to be performed at lower intra-abdominal pressures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard trocar/ IAP 15 mmHg | Active comparator | Device: Standard trocarPatients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. |
| Standard trocar/ IAP 10 mmHg | Active comparator | Device: Standard trocarPatients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. |
| AirSeal trocar/ IAP 15 mmHg | Active comparator | Device: AirSeal trocarPatients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg. |
| AirSeal trocar/ IAP 10 mmHg | Active comparator | Device: AirSeal trocarPatients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any woman ≥ 18 years of age undergoing a gynecologic laparoscopic procedure
- Able to understand the consenting process and willing to participate in study
Key exclusion criteria (2 listed)
- Patient unable to undergo laparoscopic procedure due to size of pathology or medical comorbidities
- Emergent surgery
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 |
|---|---|---|
| AirSeal trocarThe AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes. | Device | AirSeal trocar/ IAP 10 mmHg, AirSeal trocar/ IAP 15 mmHg |
| Standard trocarA standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas. | Device | Standard trocar/ IAP 10 mmHg, Standard trocar/ IAP 15 mmHg |
Primary outcome
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg
Time frame: 15 minutes & 60 minutes from surgery start time
This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases < 60 minutes, the CO2 absorption rate at 15 minutes will be used.
4 secondary outcomes
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Time frame: At the end of surgery (approximately 1 hour)
Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars
Time frame: At the end of surgery (approximately 1 hour)
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
Time frame: 4 to 6 hours, and 12 to 23 hours following surgery
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg
Time frame: 15 minutes & 60 minutes from surgery start time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20888033Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2.
- Background: PubMed 1394755Tan PL, Lee TL, Tweed WA. Carbon dioxide absorption and gas exchange during pelvic laparoscopy. Can J Anaesth. 1992 Sep;39(7):677-81. doi: 10.1007/BF03008229.
- Background: PubMed 16517337Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. doi: 10.1016/j.jclinane.2005.01.013.
- Background: PubMed 11498317Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5. doi: 10.1016/s0952-8180(01)00286-0.
- BackgroundCONMED - Transforming Laparosopic Surgery. Available at: http://www.conmed.com/en/hybrid-product-landing-pages/airseal. Retrieved January 12, 2018.
- Background: PubMed 7637101Wolf JS Jr, Monk TG, McDougall EM, McClennan BL, Clayman RV. The extraperitoneal approach and subcutaneous emphysema are associated with greater absorption of carbon dioxide during laparoscopic renal surgery. J Urol. 1995 Sep;154(3):959-63.
- Background: PubMed 10492177Ng CS, Gill IS, Sung GT, Whalley DG, Graham R, Schweizer D. Retroperitoneoscopic surgery is not associated with increased carbon dioxide absorption. J Urol. 1999 Oct;162(4):1268-72.
- Background: PubMed 4266615Motew M, Ivankovich AD, Bieniarz J, Albrecht RF, Zahed B, Scommegna A. Cardiovascular effects and acid-base and blood gas changes during laparoscopy. Am J Obstet Gynecol. 1973 Apr 1;115(7):1002-12. doi: 10.1016/0002-9378(73)90683-2. No abstract available.
- Background: PubMed 19542853Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012.
- Background: PubMed 12632130Sefr R, Puszkailer K, Jagos F. Randomized trial of different intraabdominal pressures and acid-base balance alterations during laparoscopic cholecystectomy. Surg Endosc. 2003 Jun;17(6):947-50. doi: 10.1007/s00464-002-9046-9. Epub 2003 Mar 14.
- Background: PubMed 24686347Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980.
- Background: PubMed 26275545Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
- 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.
Timothy Ryntz, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirSeal trocar and Standard trocar in people with Gynecologic Diseases, run by Columbia University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg (time frame: 15 minutes & 60 minutes from surgery start time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654808, which also lists 16 linked publications.
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 16 Sep 2021.