ObesityNCT00495222
Endoscopic Suturing System for Tissue Apposition
A study testing Tissue plication and Endoscopic Suturing System in people with Obesity, run by Ethicon Endo-Surgery at 1 site in United States.
Trial summary
The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Tissue plication and Endoscopic Suturing System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2008
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must fulfill the following criteria to be entered in this study:
- Review and sign informed consent;
- Between 21 and 65 years of age (inclusive) at time of trial enrollment;
- Documented Roux-en-Y Gastric Bypass (RYGB) surgery date
- Documented baseline weight at the time of RYGB procedure;
- > 12 months post RYGB);
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- Body mass Index (BMI) > 30 and at least 20 pounds in excess of post-RYGB weight nadir;
- Patients initially achieved at least 50% excess weight loss (EWL) post RYGB;
- Visible anastomotic junction (between gastric pouch and the Roux-limb);
- Stoma size at screening > 15mm; and
- Negative serum pregnancy test for women of childbearing potential.
Who cannot join
- Subjects will be excluded from the trial for any of the following:
- Documented history of esophageal pathology (e.g., esophageal varices, Barrett's Esophagus);
- American Anesthesia Association (ASA) Class IV or V and/or any contraindications to monitored anesthesia;
- Documented history of GJ anastomosis stricture (within 6 months);
- Documented history of previous RYGB revision;
- Presence or documented presence of gastric/duodenal ulcers;
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- Presence of sepsis;
- Medical or physical endoscopic contraindications, including esophageal varices or bleeding, laryngeal perforation, trauma to pharynx, aspiration pneumonia, acute peritonitis, and other conditions where general endoscopic techniques and/or placement of overtube are contraindicated;
- Chronic Non-Steroidal Anti-Inflammatory Drug (NSAID) use (subjects taking a single aspirin tablet per day for cardioprotection are considered acceptable);
- Uncontrolled diabetes;
- Physical or psychological condition which would impair trial participation per investigator discretion;
- Binge-eating or similar eating disorders;
- Unable or unwilling to attend follow-up visits and examinations;
- Concurrent surgical procedure (intra-operative exclusion during ESS procedure);
- Participation in any other investigational device or drug trial within 30 days prior to enrollment; or
- Any condition, which precludes compliance with the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Evaluation of an Endoscopic Suturing System for Tissue Apposition
The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Post-procedure weight will be followed to assess whether weight loss is resumed.
The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to facilitate endoscopic gastrointestinal procedures.
- Conditions
- Obesity
- Being tested
- Tissue plication, Endoscopic Suturing System
- Keywords
- gastrojejunostomy, stoma
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue plicationProcedure or surgery
Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System
Endoscopic Suturing SystemDevice
Tissue plication of dilated GJ stoma
Tissue PlicationDevice
Tissue plication for GJ stoma reduction
| Study group | Role | What they receive |
|---|---|---|
| Tissue plication | Experimental | The Endoscopic Suturing System (ESS) is used for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass Receives: Procedure: Tissue plication; Device: Endoscopic Suturing System; Device: Tissue Plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knotting Elements Placed
completion of plication (1-3 knotting elements placed per procedure)
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionApr 2008
- Study completionJun 2008
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alfonso Torquati, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495222
- Sponsor's protocol ID
- CI-06-0005
- Status last verified
- Sep 2009
- First submitted
- 29 Jun 2007
- Last updated
- 10 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Endoscopic Suturing System for Tissue Apposition
- ClinicalTrials.gov ID
- NCT00495222
- Acronym / sponsor ID
- CI-06-0005
- Conditions
- Obesity
- Keywords
- gastrojejunostomy, stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Posted 11 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Post-procedure weight will be followed to assess whether weight loss is resumed.
The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to facilitate endoscopic gastrointestinal procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue plication | Experimental | Procedure: Tissue plication, Device: Endoscopic Suturing System, Device: Tissue PlicationThe Endoscopic Suturing System (ESS) is used for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Review and sign informed consent;
- Between 21 and 65 years of age (inclusive) at time of trial enrollment;
- Documented Roux-en-Y Gastric Bypass (RYGB) surgery date
- Documented baseline weight at the time of RYGB procedure;
- > 12 months post RYGB);
Key exclusion criteria (16 listed)
- Documented history of esophageal pathology (e.g., esophageal varices, Barrett's Esophagus);
- American Anesthesia Association (ASA) Class IV or V and/or any contraindications to monitored anesthesia;
- Documented history of GJ anastomosis stricture (within 6 months);
- Documented history of previous RYGB revision;
- Presence or documented presence of gastric/duodenal ulcers;
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 |
|---|---|---|
| Tissue plicationTissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System | Procedure or surgery | Tissue plication |
| Endoscopic Suturing SystemTissue plication of dilated GJ stoma | Device | Tissue plication |
| Tissue PlicationTissue plication for GJ stoma reduction | Device | Tissue plication |
Primary outcome
Knotting Elements Placed
Time frame: intra-operative
completion of plication (1-3 knotting elements placed per procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2009.
- 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.
Alfonso Torquati, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue plication and Endoscopic Suturing System in people with Obesity, run by Ethicon Endo-Surgery 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 11 inclusion and 16 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 10 Sep 2009. 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 11 Aug 2009). 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?
Knotting Elements Placed (time frame: intra-operative). 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 10 Sep 2009.