ObesityNCT04712526
Endostapler Gastric Bypass 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 evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery. 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
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2021to Dec 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 subjects
Who may be able to join
- Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
- 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 PTT > 45sec, or PT> 15sec, or 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: Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.
Read the detailed description
Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB 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
- 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
| Study group | Role | What they receive |
|---|---|---|
| AEON Endostapler | Stapling performed with AEON Endostapler Receives: Device: AEON Endostapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reported device-related adverse events
Measured: Within 30-day post-operative period
Secondary outcomes (4)
Endoscopic staple line bleeding
Incidence of intraoperative staple line bleeding from endoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Endoscope Images (1: No bleeding, 5: Profuse Bleeding)
Measured: Within surgery
Laparoscopic staple line bleeding
Incidence of intraoperative staple line bleeding from laparoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Laparoscope Images (1: No bleeding, 5: Profuse Bleeding)
Measured: Within surgery
Incidence of intraoperative or postoperative blood transfusion
Measured: Within 72 hours of surgery start time
Incidence of product malfunction
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 posted15 Jan 2021
- Study start18 Jan 2021
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: voluntarily withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT04712526
- Sponsor's protocol ID
- Endostapler03
- Status last verified
- Oct 2023
- First submitted
- 13 Jan 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT04712526
- Acronym / sponsor ID
- Endostapler03
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: voluntarily withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lexington Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Jan 2021 (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.
The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.
Detailed description
Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB 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
- 1
| Arm | Type | Receives |
|---|---|---|
| AEON Endostapler | – | Device: AEON EndostaplerStapling performed with AEON Endostapler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 subjects
Key inclusion criteria (2 listed)
- Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
- 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 PTT > 45sec, or PT> 15sec, or 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 |
Primary outcome
Incidence of reported device-related adverse events
Time frame: Within 30-day post-operative period
4 secondary outcomes
Endoscopic staple line bleeding
Time frame: Within surgery
Laparoscopic staple line bleeding
Time frame: Within surgery
Incidence of intraoperative or postoperative blood transfusion
Time frame: Within 72 hours of surgery start time
Incidence of product malfunction
Time frame: Within surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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: withdrawn, as of the sponsor's last update on 4 Oct 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of reported device-related adverse events (time frame: Within 30-day post-operative period). 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 4 Oct 2023; AzTrials last refreshed its copy on 28 Oct 2026.