Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity ScaleNCT04149925
Endostapler Hemostasis Study
An observational study of Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale, run by Lexington Medical Inc. at 3 sites in United States.
Trial summary
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
- What is being tested?
- AEON Endostapler and Echelon Flex Powered Stapler
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Oct 2019to 14 Feb 2020
- How long will I take part?
- 1 Month
- 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: See above
Who may be able to join
- Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
- Informed consent for study obtained and signed from each subject
Who cannot join
- Planned open surgical approach
- Prior bariatric operation (i.e. revisional bariatric surgery)
- Use of staple line reinforcement material (buttress)
- Patients taking anticoagulants
- Patients under the age of 18 on the date of the surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Avala Hospital
Covington, Louisiana, 70433
Crescent City Surgical Centre
Metairie, Louisiana, 70001
Southern Surgical Hospital
Slidell, Louisiana, 70458
About this study
Official title: Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. 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. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.
- Being tested
- AEON Endostapler, Echelon Flex Powered Stapler
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
Echelon Flex Powered StaplerDevice
Surgery with Echelon Flex Powered Stapler
| Study group | Role | What they receive |
|---|---|---|
| AEON Endostapler | Stapling performed by AEON Endostapler Receives: Device: AEON Endostapler | |
| Echelon Flex Powered Stapler | Stapling performed by Echelon Flex Powered Stapler Receives: Device: Echelon Flex Powered Stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staple Line Bleeding
Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)
Measured: 10 seconds after last staple line
Secondary outcomes (5)
Staple Line Leaking
Incidence of postoperative leakage during one-month monitoring period following procedure
Measured: 1 month following procedure
Adverse Events
Incidence of reported device-related adverse events
Measured: 1 month following procedure
Product Malfunction
Incidence of product malfunction during procedure
Measured: During surgery
Blood Transfusion
Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time
Measured: Within 72 hours of surgery start
Pain Level
Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain.
Measured: 1 week following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start22 Oct 2019
- Primary completion24 Jan 2020
- Study completion14 Feb 2020
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 Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity ScaleStudies 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)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Lexington Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Surgical Specialists of Louisiana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149925
- Sponsor's protocol ID
- Endostapler01
- Status last verified
- Feb 2021
- First submitted
- 31 Oct 2019
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler
- ClinicalTrials.gov ID
- NCT04149925
- Acronym / sponsor ID
- Endostapler01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lexington Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Surgical Specialists of Louisiana
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 8 Apr 2020
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, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. 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. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEON Endostapler | – | Device: AEON EndostaplerStapling performed by AEON Endostapler |
| Echelon Flex Powered Stapler | – | Device: Echelon Flex Powered StaplerStapling performed by Echelon Flex Powered Stapler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- See above
Key inclusion criteria (2 listed)
- Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
- Informed consent for study obtained and signed from each subject
Key exclusion criteria (5 listed)
- Planned open surgical approach
- Prior bariatric operation (i.e. revisional bariatric surgery)
- Use of staple line reinforcement material (buttress)
- Patients taking anticoagulants
- Patients under the age of 18 on the date of the 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 |
|---|---|---|
| AEON EndostaplerSurgery with AEON Endostapler | Device | AEON Endostapler |
| Echelon Flex Powered StaplerSurgery with Echelon Flex Powered Stapler | Device | Echelon Flex Powered Stapler |
Primary outcome
Staple Line Bleeding
Time frame: 10 seconds after last staple line
Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)
5 secondary outcomes
Staple Line Leaking
Time frame: 1 month following procedure
Adverse Events
Time frame: 1 month following procedure
Product Malfunction
Time frame: During surgery
Blood Transfusion
Time frame: Within 72 hours of surgery start
Pain Level
Time frame: 1 week following procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale, run by Lexington Medical Inc. at 3 sites 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 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: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 8 Apr 2020). 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?
Staple Line Bleeding (time frame: 10 seconds after last staple line). 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 23 Feb 2021.