Endoscopic Suturing Within the Gastrointestinal TractNCT02166125
Endoscopic Sutures For Gastrointestinal Tract Disorders: A Prospective Multicenter Registry
An observational study of Endoscopic Suturing Within the Gastrointestinal Tract, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Endoscopic Suturing Within the Gastrointestinal Tract
- What is being tested?
- Endosuturing
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2013to 26 Aug 2017
- How long will I take part?
- 1 Year
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract.
Who may be able to join
- Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract
- Above or equal to 18 years of age
Who cannot join
- Any patient who has not undergone endoscopic suturing within the gastrointestinal tract
- Below 18 years of age
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Digestive Health Associates of Texas
Dallas, Texas, 75208
Prashant Kedia, MD, 214-941-6891, prashant.kedia@dhat.com
- Recruiting
Ochsner Health Center - Kenner
Kenner, Louisiana, 70065
Virendra Joshi, MD, 504-464-8588, vjoshi@ochsner.org
- Recruiting
Weill Cornell Medical College
New York, New York, 10021
Michel Kahaleh, MD, 646-962-4797, mkahaleh@gmail.com
Monica R Gaidhane, MD, MPH, 646-962-4796, mog2012@med.cornell.edu
About this study
Official title: Endoscopic Sutures For Gastrointestinal Tract Disorders: A Prospective Multicenter Registry.
The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.
Read the detailed description
Our institution performs therapeutic Interventional Endoscopy in around 500-1000 patients a year. We come across several gastrointestinal disorders such as fistula or leak repairs, gastric outlet revisions, (dilated anastomoses), stent migrations, gastric wall defects or perforation, ulcer repairs, closure of transgastric entrance after a NOTES procedure (Natural orifice translumenal endoscopic surgery) that require placement of sutures and/or approximation of soft tissue.
Conventionally, surgery or other endoscopic alternatives are used to resolve or mitigate these issues. However, surgery had higher morbidity and mortality rates, and other endoscopic alternatives may not be successful either.
With the advent of endoscopic suture systems such as the Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) (or Endo Stitch™ , the SILS™ Stitch), advanced endoscopists can place endoscopic sutures by deploying multiple running and interrupted stitches with a single insertion of the endoscope within the gastrointestinal tract.
Currently, the endoscopy unit uses the Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) for suture placement in various gastrointestinal disorders; including suturing stents to prevent stent migration in the esophagus. Even though several case reports and animal studies have been published reporting the clinical success of endoscopic suturing, there have been hardly any large sample size studies to verify the safety and efficacy of endoscopic suturing. Our own study reported 12 cases with promising results for esophageal stent subjects. 1-16 We lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.
The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.
Study Design: Prospective, observational, medical chart review for at least 6 standard of care visits up to 1 year after subject consents for study participation.
Interventions: None
Subject Participation: Subject's participation in this study will allow us to collect data for at least 6 standard of care visits up to 1 year after consenting to participating in this registry study.
Subject will undergo a standard of care or clinically indicated Endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care. Subject will sign a separate clinical consent for the Endoscopic procedure and placement of the sutures(s). That consent form will explain the procedure as well as the risks involved with the procedure.
Subject will undergo endoscopic suturing and subsequent follow up clinic visits regardless of their participation in this study. Subject will undergo no additional tests and procedures as part of this study.
This registry study allows for the prospective review and collection of clinical data related to endoscopic suturing for safety and efficacy assessment.
Study duration: At least 6 standard of care visits up to 1 year for each subject
- Once the subject consents, data will be collected for their clinically indicated or standard of care procedure visit and follow up visits.
- Standard of care follow up visits for endoscopic suturing are usually 1 month, 3 months and 6 months post procedure. No additional research related visits will be requested.
- All data will be collected from Medical charts.
- No subject surveys or questionnaires will be administered.
- Being tested
- Endosuturing
- Keywords
- gastric bypass, sleeve gastrectomy, esophageal stent, suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndosuturingProcedure or surgery
Endoscopic suturing
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic suturing | Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract. Receives: Procedure: Endosuturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Documentation of technical success and clinical outcome rates. Technical success will be documented via number of sutures successfully placed. Clinical success will be documented via follow up of resolution of symptoms of primary indication and number of repeat interventions or other interventions for the same indication.
Measured: 6 months to 1 year
Secondary outcomes (1)
Safety Outcome
Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMay 2013
- Primary completion26 May 2017 (estimated)
- Study completion26 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Suturing Within the Gastrointestinal TractStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Kahaleh, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166125
- Sponsor's protocol ID
- 1207012584
- Status last verified
- Feb 2017
- First submitted
- 10 Jun 2014
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sutures For Gastrointestinal Tract Disorders: A Prospective Multicenter Registry.
- ClinicalTrials.gov ID
- NCT02166125
- Acronym / sponsor ID
- 1207012584
- Keywords
- gastric bypass, sleeve gastrectomy, esophageal stent, suturing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 26 May 2017 (estimated)
- Study completion
- 26 Aug 2017 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- 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 purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.
Detailed description
Our institution performs therapeutic Interventional Endoscopy in around 500-1000 patients a year. We come across several gastrointestinal disorders such as fistula or leak repairs, gastric outlet revisions, (dilated anastomoses), stent migrations, gastric wall defects or perforation, ulcer repairs, closure of transgastric entrance after a NOTES procedure (Natural orifice translumenal endoscopic surgery) that require placement of sutures and/or approximation of soft tissue.
Conventionally, surgery or other endoscopic alternatives are used to resolve or mitigate these issues. However, surgery had higher morbidity and mortality rates, and other endoscopic alternatives may not be successful either.
With the advent of endoscopic suture systems such as the Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) (or Endo Stitch™ , the SILS™ Stitch), advanced endoscopists can place endoscopic sutures by deploying multiple running and interrupted stitches with a single insertion of the endoscope within the gastrointestinal tract.
Currently, the endoscopy unit uses the Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) for suture placement in various gastrointestinal disorders; including suturing stents to prevent stent migration in the esophagus. Even though several case reports and animal studies have been published reporting the clinical success of endoscopic suturing, there have been hardly any large sample size studies to verify the safety and efficacy of endoscopic suturing. Our own study reported 12 cases with promising results for esophageal stent subjects. 1-16 We lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.
The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.
Study Design: Prospective, observational, medical chart review for at least 6 standard of care visits up to 1 year after subject consents for study participation.
Interventions: None
Subject Participation: Subject's participation in this study will allow us to collect data for at least 6 standard of care visits up to 1 year after consenting to participating in this registry study.
Subject will undergo a standard of care or clinically indicated Endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care. Subject will sign a separate clinical consent for the Endoscopic procedure and placement of the sutures(s). That consent form will explain the procedure as well as the risks involved with the procedure.
Subject will undergo endoscopic suturing and subsequent follow up clinic visits regardless of their participation in this study. Subject will undergo no additional tests and procedures as part of this study.
This registry study allows for the prospective review and collection of clinical data related to endoscopic suturing for safety and efficacy assessment.
Study duration: At least 6 standard of care visits up to 1 year for each subject
- Once the subject consents, data will be collected for their clinically indicated or standard of care procedure visit and follow up visits.
- Standard of care follow up visits for endoscopic suturing are usually 1 month, 3 months and 6 months post procedure. No additional research related visits will be requested.
- All data will be collected from Medical charts.
- No subject surveys or questionnaires will be administered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic suturing | – | Procedure: EndosuturingAny patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract.
Key inclusion criteria (2 listed)
- Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract
- Above or equal to 18 years of age
Key exclusion criteria (2 listed)
- Any patient who has not undergone endoscopic suturing within the gastrointestinal tract
- Below 18 years of age
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 |
|---|---|---|
| EndosuturingEndoscopic suturing | Procedure or surgery | Endoscopic suturing |
Primary outcome
Clinical Success
Time frame: 6 months to 1 year
Documentation of technical success and clinical outcome rates. Technical success will be documented via number of sutures successfully placed. Clinical success will be documented via follow up of resolution of symptoms of primary indication and number of repeat interventions or other interventions for the same indication.
1 secondary outcome
Safety Outcome
Time frame: 30 days post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Individual participant dataSharing planned: No. No IPD sharing
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.
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 Endoscopic Suturing Within the Gastrointestinal Tract, run by Weill Medical College of Cornell University 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 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Kahaleh, MD (646-962-4797, mik9071@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 6 months to 1 year). 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 20 Feb 2017.