Morbid ObesityNCT02731079
Sleeve Gastrectomy Outcomes With Different Stapling Devices
A study testing Covidien iDrive and Ethicon Echilon in people with Morbid Obesity, run by Edna Rath at 1 site in United States.
Trial summary
Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the investigators are unaware of any studies that compare outcomes between devices from the two main stapler manufacturers used in this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Covidien iDrive and Ethicon Echilon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 22 Dec 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained and signed from each subject
- Age ≥ 18 years
- Requirement for agreement to avoid conception
- BMI >40
- BMI >35 with obesity-related co-morbidity
- Pre-operative psychiatric evaluation
- Pre-operative laboratory studies that fail to demonstrate secondary cause of obesity
- Full course of triple therapy for patients with Helicobacter pylori on upper endoscopy
Who cannot join
- Pregnancy- Patients are not eligible for bariatric surgery, and if they become pregnant after surgery, they would present confounding variables and alter weight loss
- Tobacco use within one month of surgery or any time within study period- Most staff will not perform bariatric surgery on active smokers as it negatively impacts healing
- Prior bariatric surgery- Makes repeat bariatric surgery more difficult and could increase risk of complications
- Inflammatory bowel disease- Rare diagnosis that may increase chance of complications, thus confounding results
- Active duty military- Not eligible for bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Army Medical Center
El Paso, Texas, 79934
About this study
Official title: Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices
Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the investigators are unaware of any studies that compare outcomes between devices from the two main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this study is to compare intraoperative characteristics, such as time to create sleeve, intraoperative bleeding, and time needed to load each cartridge, and post-operative characteristics, such as any complication requiring readmission (leak or hemorrhage), further surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy with Covidien devices and Ethicon devices. Currently the investigators predominantly use whatever device is cheaper, but cost should not be the primary decisive factor if one device is superior to the other. If one device has better clinical outcomes, it should be the preferred device regardless of cost. If neither proves superiority, the investigators can justify using cost to determine which device to use in patient care.
Read the detailed description
New bariatric patients who have elected for a sleeve gastrectomy as part of standard of care will be invited to participate in the study during the bariatric clinic at William Beaumont Army Medical Center. Patients who meet the inclusion criteria will be invited to participate in the study. These patients will be consented in the bariatric clinic by a research coordinator (Doreen Bandari-Spaulding) or physician listed on the study if the coordinator is unavailable.
Three folders will be made, one for each bariatric surgeon, and 25 Covidien cards and 25 Ethicon cards will be placed into each for a total of 150 patients. All bariatric surgeons are trained and familiar with both devices. Once consented, a card will be removed at random to determine which stapler will be used. Bioabsorbable staple line reinforcement will be utilized with both staplers. Once in the operating room, the case start time, time from first staple firing to completion of sleeve, total stapler loads required, number of staple misfires, character of any staple line bleeding, and time for tech to load each cartridge will be recorded on a data collection sheet by a research resident, listed as an associative investigator on this protocol. The subject's post-operative course will follow the bariatric protocol. During follow-up, they will be monitored for weight loss, post-operative complications, and any other required interventions. This information will be obtained by reviewing the subject's medical record after follow-up appointments. Per the institutional bariatric protocol, subjects will follow-up at 3 weeks, 6 weeks, 3 months, 6 months, and annually. If a subject withdraws consent for the study prior to surgery, they will still receive surgery and perioperative treatment in line with institutional protocol, and they will be withdrawn and create a vacancy for a new subject. If a subject withdraws consent after surgery, data collection will cease for that subject. The investigators will clarify whether they want all data to be removed from the study or if they simply want no more data to be entered into the study and abide by their wishes, and they will remain in the original randomized group in accordance with intention-to-treat principles.
- Conditions
- Morbid Obesity
- Being tested
- Covidien iDrive, Ethicon Echilon
- Keywords
- Sleeve gastrectomy stapler Covidien Ethicon bleeding leak
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covidien iDriveDevice
Surgery performed with Covidien powered stapler
Ethicon EchilonDevice
Surgery performed with Ethicon powered stapler
| Study group | Role | What they receive |
|---|---|---|
| Covidien | Active comparator | Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement. Receives: Device: Covidien iDrive |
| Ethicon | Active comparator | Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement. Receives: Device: Ethicon Echilon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Time to create sleeve.
Measured: Time from first staple firing to last staple firing, for up to 5 hours
Staple Firings With Technical Difficulties
Percent of staple firings with technical difficulties
Measured: Time from first staple firing to last staple firing, for up to 5 hours
Load Time
Time to load staple cartridges
Measured: Time from first staple firing to last staple firing, for up to 5 hours
Secondary outcomes (5)
Intra-operative Staple Line Bleeding
Will note any incidental bleeding along staple line and how many maneuvers were needed to control it. Measured as: 1) None, 2) Single therapy, 3) Multiple therapy (Any combination of hemostatic modalities)
Measured: Time from first staple firing to end of the case, for up to 5 hours
Weight Loss
Weight loss in percent excess body weight loss at 3 weeks, 6 weeks, 3 months, 6 months, and up to 1 year
Measured: Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation
Leak Rates
Staple line leak rates
Measured: Immediate post-operative period to conclusion of study, for up to 5 hours
Readmissions
Hospital readmissions or emergency room visits; Will note reason for readmission
Measured: Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation
Sleeve-related Complications Requiring Surgery, Recorded as Yes or no
Will note intervention required and indication; reasons include, but are not limiting to, staple line leak, hematoma, abscess, prolonged tachycardia suspicious for intra-abdominal pathology
Measured: Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start22 Jan 2018
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Why it stopped: Study expired before any data was analyzed.
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 (12)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edna Rath
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Edna Rath, William Beaumont Army Medical Center
- Investigators
- Eric P Ahnfeldt, DO, Principal investigator, Residency Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731079
- Sponsor's protocol ID
- WB16-08
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2016
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg. 2013 Feb;216(2):252-7. doi: 10.1016/j.jamcollsurg.2012.10.003. Epub 2012 Nov 21.
PubMed 23177371Marceau P, Hould FS, Simard S, Lebel S, Bourque RA, Potvin M, Biron S. Biliopancreatic diversion with duodenal switch. World J Surg. 1998 Sep;22(9):947-54. doi: 10.1007/s002689900498.
PubMed 9717420Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a case series of 40 consecutive patients. Obes Surg. 2000 Dec;10(6):514-23; discussion 524. doi: 10.1381/096089200321593715.
PubMed 11175958Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003 Dec;13(6):861-4. doi: 10.1381/096089203322618669.
PubMed 14738671ASMBS Clinical Issues Committee. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012 May-Jun;8(3):e21-6. doi: 10.1016/j.soard.2012.02.001. Epub 2012 Feb 10. No abstract available.
PubMed 22417852D'Ugo S, Gentileschi P, Benavoli D, Cerci M, Gaspari A, Berta RD, Moretto C, Bellini R, Basso N, Casella G, Soricelli E, Cutolo P, Formisano G, Angrisani L, Anselmino M. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. Surg Obes Relat Dis. 2014 May-Jun;10(3):450-4. doi: 10.1016/j.soard.2013.10.018. Epub 2013 Nov 12.
PubMed 24448100Gentileschi P, Camperchioli I, D'Ugo S, Benavoli D, Gaspari AL. Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc. 2012 Sep;26(9):2623-9. doi: 10.1007/s00464-012-2243-2. Epub 2012 Mar 23.
PubMed 22441975Glaysher M, Khan OA, Mabvuure NT, Wan A, Reddy M, Vasilikostas G. Staple line reinforcement during laparoscopic sleeve gastrectomy: does it affect clinical outcomes? Int J Surg. 2013;11(4):286-9. doi: 10.1016/j.ijsu.2013.02.015. Epub 2013 Feb 28.
PubMed 23459188Sroka G, Milevski D, Shteinberg D, Mady H, Matter I. Minimizing Hemorrhagic Complications in Laparoscopic Sleeve Gastrectomy--a Randomized Controlled Trial. Obes Surg. 2015 Sep;25(9):1577-83. doi: 10.1007/s11695-015-1580-3.
PubMed 25596939Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):713-23. doi: 10.1016/j.soard.2014.01.016. Epub 2014 Jan 28.
PubMed 24745978Huang R, Gagner M. A Thickness Calibration Device Is Needed to Determine Staple Height and Avoid Leaks in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2360-7. doi: 10.1007/s11695-015-1705-8.
PubMed 26024735
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices
- ClinicalTrials.gov ID
- NCT02731079
- Acronym / sponsor ID
- WB16-08
- Conditions
- Morbid Obesity
- Keywords
- Sleeve gastrectomy stapler Covidien Ethicon bleeding leak
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study expired before any data was analyzed.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Edna RathUS federal agency
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Posted 12 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the investigators are unaware of any studies that compare outcomes between devices from the two main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this study is to compare intraoperative characteristics, such as time to create sleeve, intraoperative bleeding, and time needed to load each cartridge, and post-operative characteristics, such as any complication requiring readmission (leak or hemorrhage), further surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy with Covidien devices and Ethicon devices. Currently the investigators predominantly use whatever device is cheaper, but cost should not be the primary decisive factor if one device is superior to the other. If one device has better clinical outcomes, it should be the preferred device regardless of cost. If neither proves superiority, the investigators can justify using cost to determine which device to use in patient care.
Detailed description
New bariatric patients who have elected for a sleeve gastrectomy as part of standard of care will be invited to participate in the study during the bariatric clinic at William Beaumont Army Medical Center. Patients who meet the inclusion criteria will be invited to participate in the study. These patients will be consented in the bariatric clinic by a research coordinator (Doreen Bandari-Spaulding) or physician listed on the study if the coordinator is unavailable.
Three folders will be made, one for each bariatric surgeon, and 25 Covidien cards and 25 Ethicon cards will be placed into each for a total of 150 patients. All bariatric surgeons are trained and familiar with both devices. Once consented, a card will be removed at random to determine which stapler will be used. Bioabsorbable staple line reinforcement will be utilized with both staplers. Once in the operating room, the case start time, time from first staple firing to completion of sleeve, total stapler loads required, number of staple misfires, character of any staple line bleeding, and time for tech to load each cartridge will be recorded on a data collection sheet by a research resident, listed as an associative investigator on this protocol. The subject's post-operative course will follow the bariatric protocol. During follow-up, they will be monitored for weight loss, post-operative complications, and any other required interventions. This information will be obtained by reviewing the subject's medical record after follow-up appointments. Per the institutional bariatric protocol, subjects will follow-up at 3 weeks, 6 weeks, 3 months, 6 months, and annually. If a subject withdraws consent for the study prior to surgery, they will still receive surgery and perioperative treatment in line with institutional protocol, and they will be withdrawn and create a vacancy for a new subject. If a subject withdraws consent after surgery, data collection will cease for that subject. The investigators will clarify whether they want all data to be removed from the study or if they simply want no more data to be entered into the study and abide by their wishes, and they will remain in the original randomized group in accordance with intention-to-treat principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covidien | Active comparator | Device: Covidien iDriveGroup that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement. |
| Ethicon | Active comparator | Device: Ethicon EchilonGroup that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent obtained and signed from each subject
- Age ≥ 18 years
- Requirement for agreement to avoid conception
- BMI >40
- BMI >35 with obesity-related co-morbidity
Key exclusion criteria (5 listed)
- Pregnancy- Patients are not eligible for bariatric surgery, and if they become pregnant after surgery, they would present confounding variables and alter weight loss
- Tobacco use within one month of surgery or any time within study period- Most staff will not perform bariatric surgery on active smokers as it negatively impacts healing
- Prior bariatric surgery- Makes repeat bariatric surgery more difficult and could increase risk of complications
- Inflammatory bowel disease- Rare diagnosis that may increase chance of complications, thus confounding results
- Active duty military- Not eligible for bariatric 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 |
|---|---|---|
| Covidien iDriveSurgery performed with Covidien powered stapler | Device | Covidien |
| Ethicon EchilonSurgery performed with Ethicon powered stapler | Device | Ethicon |
Primary outcome
Time
Time frame: Time from first staple firing to last staple firing, for up to 5 hours
Time to create sleeve.
Staple Firings With Technical Difficulties
Time frame: Time from first staple firing to last staple firing, for up to 5 hours
Percent of staple firings with technical difficulties
Load Time
Time frame: Time from first staple firing to last staple firing, for up to 5 hours
Time to load staple cartridges
5 secondary outcomes
Intra-operative Staple Line Bleeding
Time frame: Time from first staple firing to end of the case, for up to 5 hours
Weight Loss
Time frame: Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation
Leak Rates
Time frame: Immediate post-operative period to conclusion of study, for up to 5 hours
Readmissions
Time frame: Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation
Sleeve-related Complications Requiring Surgery, Recorded as Yes or no
Time frame: Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Background: PubMed 23177371Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg. 2013 Feb;216(2):252-7. doi: 10.1016/j.jamcollsurg.2012.10.003. Epub 2012 Nov 21.
- Background: PubMed 9717420Marceau P, Hould FS, Simard S, Lebel S, Bourque RA, Potvin M, Biron S. Biliopancreatic diversion with duodenal switch. World J Surg. 1998 Sep;22(9):947-54. doi: 10.1007/s002689900498.
- Background: PubMed 11175958Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a case series of 40 consecutive patients. Obes Surg. 2000 Dec;10(6):514-23; discussion 524. doi: 10.1381/096089200321593715.
- Background: PubMed 14738671Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003 Dec;13(6):861-4. doi: 10.1381/096089203322618669.
- Background: PubMed 22417852ASMBS Clinical Issues Committee. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012 May-Jun;8(3):e21-6. doi: 10.1016/j.soard.2012.02.001. Epub 2012 Feb 10. No abstract available.
- Background: PubMed 24448100D'Ugo S, Gentileschi P, Benavoli D, Cerci M, Gaspari A, Berta RD, Moretto C, Bellini R, Basso N, Casella G, Soricelli E, Cutolo P, Formisano G, Angrisani L, Anselmino M. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. Surg Obes Relat Dis. 2014 May-Jun;10(3):450-4. doi: 10.1016/j.soard.2013.10.018. Epub 2013 Nov 12.
- Background: PubMed 22441975Gentileschi P, Camperchioli I, D'Ugo S, Benavoli D, Gaspari AL. Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc. 2012 Sep;26(9):2623-9. doi: 10.1007/s00464-012-2243-2. Epub 2012 Mar 23.
- Background: PubMed 23459188Glaysher M, Khan OA, Mabvuure NT, Wan A, Reddy M, Vasilikostas G. Staple line reinforcement during laparoscopic sleeve gastrectomy: does it affect clinical outcomes? Int J Surg. 2013;11(4):286-9. doi: 10.1016/j.ijsu.2013.02.015. Epub 2013 Feb 28.
- Background: PubMed 25596939Sroka G, Milevski D, Shteinberg D, Mady H, Matter I. Minimizing Hemorrhagic Complications in Laparoscopic Sleeve Gastrectomy--a Randomized Controlled Trial. Obes Surg. 2015 Sep;25(9):1577-83. doi: 10.1007/s11695-015-1580-3.
- Background: PubMed 24745978Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):713-23. doi: 10.1016/j.soard.2014.01.016. Epub 2014 Jan 28.
- Background: PubMed 26024735Huang R, Gagner M. A Thickness Calibration Device Is Needed to Determine Staple Height and Avoid Leaks in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2360-7. doi: 10.1007/s11695-015-1705-8.
- Individual participant dataSharing planned: Undecided
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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.
Eric P Ahnfeldt, DO principal investigator
Residency Program Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covidien iDrive and Ethicon Echilon in people with Morbid Obesity, run by Edna Rath 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 8 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: stopped early, as of the sponsor's last update on 12 Jan 2026. 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 12 Jan 2026). 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?
Time (time frame: Time from first staple firing to last staple firing, for up to 5 hours). The study lists 3 primary outcomes in all. 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 NCT02731079, which also lists 12 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 12 Jan 2026.