ObesityNCT04617574
Endostapler Sleeve Gastrectomy Study
An observational study of Obesity, run by Lexington Medical Inc. at 1 site in United States.
Trial summary
The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- AEON Endostapler and Endo GIA Reloads with Tri-Staple Technology
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 10 Jul 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 subjects
Who may be able to join
- Patients undergoing planned laparoscopic sleeve gastrectomy
- Informed consent for study obtained and signed from each subject
Who cannot join
- Planned open surgical approach
- Use of staple line reinforcement material (buttress)
- Revision or other bariatric procedure
- Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or Partial Thromboplastin Time (PTT) >45sec, or Prothrombin Time (PT) >15sec, or International Normalized Ratio (INR) >1.5
- Patients with active HIV or Hepatitis B
- Patients under the age of 18 on the date of the surgery
Show all 9Show fewer
- Patients who are pregnant
- Patients using tobacco products within the last 2 weeks prior to surgery date
- Patients using cortisone or related products within the last 2 weeks prior to surgery date
Trial locations and contacts
1 site in 1 country.
United States1 site
Holyoke Medical Center
Holyoke, Massachusetts, 01040
About this study
Official title: A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy
The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.
Read the detailed description
Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.
- Conditions
- Obesity
- Being tested
- AEON Endostapler, Endo GIA Reloads with Tri-Staple Technology
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEON EndostaplerDevice
Surgery with AEON Endostapler
Endo GIA Reloads with Tri-Staple TechnologyDevice
Surgery with Endo GIA Reloads with Tri-Staple Technology
| Study group | Role | What they receive |
|---|---|---|
| AEON Endostapler | Stapling performed with AEON Endostapler Receives: Device: AEON Endostapler | |
| Endo GIA Reloads with Tri-Staple Technology | Stapling performed with Endo GIA Reloads with Tri-Staple Technology Receives: Device: Endo GIA Reloads with Tri-Staple Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Endoscopic Staple Line Bleeding Score
Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
Measured: Within surgery, after the last stapler firing
Intraoperative Laparoscopic Staple Line Bleeding Score
Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
Measured: Within surgery, images captured 10 seconds after the last stapler firing
Secondary outcomes (4)
Number of Participants With Postoperative Leakage Requiring Intervention
Number of participants with postoperative leakage requiring intervention
Measured: Within 30-day post-operative period
Number of Participants With Intraoperative or Postoperative Blood Transfusion
Number of participants with intraoperative or postoperative blood transfusion
Measured: Within 72 hours of surgery start time
Number of Participants With Reported Device-related Adverse Events
Number of participants with reported device-related adverse events
Measured: Within 30-day post-operative period
Number of Participants With Product Malfunction
Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.
Measured: Within surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start15 Sep 2020
- Primary completion10 Jun 2021
- Study completion10 Jul 2021
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.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexington Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617574
- Sponsor's protocol ID
- Endostapler02
- Status last verified
- Sep 2021
- First submitted
- 2 Nov 2020
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04617574
- Acronym / sponsor ID
- Endostapler02
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lexington Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.
Detailed description
Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEON Endostapler | – | Device: AEON EndostaplerStapling performed with AEON Endostapler |
| Endo GIA Reloads with Tri-Staple Technology | – | Device: Endo GIA Reloads with Tri-Staple TechnologyStapling performed with Endo GIA Reloads with Tri-Staple Technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 subjects
Key inclusion criteria (2 listed)
- Patients undergoing planned laparoscopic sleeve gastrectomy
- Informed consent for study obtained and signed from each subject
Key exclusion criteria (9 listed)
- Planned open surgical approach
- Use of staple line reinforcement material (buttress)
- Revision or other bariatric procedure
- Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or Partial Thromboplastin Time (PTT) >45sec, or Prothrombin Time (PT) >15sec, or International Normalized Ratio (INR) >1.5
- Patients with active HIV or Hepatitis B
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 |
|---|---|---|
| AEON EndostaplerSurgery with AEON Endostapler | Device | AEON Endostapler |
| Endo GIA Reloads with Tri-Staple TechnologySurgery with Endo GIA Reloads with Tri-Staple Technology | Device | Endo GIA Reloads with Tri-Staple Technology |
Primary outcome
Intraoperative Endoscopic Staple Line Bleeding Score
Time frame: Within surgery, after the last stapler firing
Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
Intraoperative Laparoscopic Staple Line Bleeding Score
Time frame: Within surgery, images captured 10 seconds after the last stapler firing
Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
4 secondary outcomes
Number of Participants With Postoperative Leakage Requiring Intervention
Time frame: Within 30-day post-operative period
Number of Participants With Intraoperative or Postoperative Blood Transfusion
Time frame: Within 72 hours of surgery start time
Number of Participants With Reported Device-related Adverse Events
Time frame: Within 30-day post-operative period
Number of Participants With Product Malfunction
Time frame: Within surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Lexington Medical Inc. 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 9 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 22 Oct 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 22 Oct 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?
Intraoperative Endoscopic Staple Line Bleeding Score (time frame: Within surgery, after the last stapler firing). 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 Oct 2021.