Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02166125 |
| Other study ID # |
1207012584 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
June 10, 2014 |
| Last updated |
February 16, 2017 |
| Start date |
May 2013 |
| Est. completion date |
August 26, 2017 |
Study information
| Verified date |
February 2017 |
| Source |
Weill Medical College of Cornell University |
| Contact |
Michel Kahaleh, MD |
| Phone |
646-962-4797 |
| Email |
mik9071[@]med.cornell.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
