Endoscopic Suturing (ES) Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03776188|
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : May 15, 2020
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable.
To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.
|Condition or disease|
To determine patient outcomes (survival, morbidity including hospitalization, additional re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing at predetermined intervals from the last endoscopic suturing procedure or at failure of the endoscopic suturing with conversion to another intervention such as surgery and compared to historical controls when applicable.
To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation of stents and bariatric revision.
To collect data on the common use endoscopic suturing therapy in other indications.
This prospective clinical study is a real-world registry and not a randomized controlled trial. Given the conditions commonly treated with endoscopic suturing and the potential lack of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all centers, randomization of participants is not possible nor ethical. In addition, there are clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or endoprosthetics may be appropriate and open and laparoscopic surgical approaches inappropriate from an ethical viewpoint. Given the multitude of currently available minimally invasive approaches to repair, it would be unethical to expose and randomize patients who are suitable for more minimally invasive approaches to a more invasive and inherently more morbid approach.
This outcomes study is external to the subject receiving the medical device treatment. Subjects will receive the medical device treatment regardless of study participation and the surgery is not part of this research. Subjects will be consented prior to their procedure, to obtain basic follow-up information. If the subject provides informed consent to participate in the registry, then site staff will follow the participant's clinical data for the period of the registry. Site staff may also contact the subject(s) during their standard clinic visit or via the telephone and obtain information on: overall health, specific events related to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.
The clinical data will be collected during usual procedure follow-ups. This will include recording patient demographics, medications, testing results, comorbidities, body mass index, and reason for clinical care visit. If during the follow-up period, the subject undergoes additional clinically indicated procedures or hospitalizations for procedure related indications then the site will submit this information to the registry.
All procedures and device use will be performed as clinically indicated and as directed by the treating physician. All information requested as part of this registry will be obtained from clinical data obtained as part of study.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||310 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Prospective Registry for Trans-Orifice Endoscopic Suturing Applications|
|Actual Study Start Date :||October 29, 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2021|
no groups - observational study
no groups - observational study
- Dislocation of Stent - distance [ Time Frame: Change at 2 weeks, 30 days, 3 months ]Change in the position measured using distance (centimeters).
- Dislocation of Stent - location [ Time Frame: Change at 2 weeks, 30 days, 3 months ]Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter
- Migration Rate of Stent - placement [ Time Frame: Change at 2 weeks, 30 days, 3 months ]Distal from placement over time (yes or no)
- Migration Rate of Stent - replaced [ Time Frame: Change at 2 weeks, 30 days, 3 months ]Stent replaced or re-structured over time (yes or no)
- Migration Rate of Stent - sutures [ Time Frame: Change at 2 weeks, 30 days, 3 months ]Number of intact Sutures
- Migration Rate of Stent - removal [ Time Frame: Change at 2 weeks, 30 days, 3 months ]Days to removal and replacement
- Excess Weight Loss [ Time Frame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months ]Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.
- Total Weight Loss [ Time Frame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months ]Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776188
|Contact: Sonya M Serra, MScfirstname.lastname@example.org|
|Contact: Yanina Nersesova, MAemail@example.com|
|United States, Arkansas|
|University of Arkansas||Recruiting|
|Little Rock, Arkansas, United States, 72211|
|Contact: Sumant Inamdar, MD|
|Principal Investigator: Sumant Inamdar, MD|
|United States, Florida|
|Mayo Clinic Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Thomas Morse|
|Principal Investigator: Victoria Gomez, MD|
|Borland Grover Clinic||Recruiting|
|Jacksonville, Florida, United States, 32256|
|Contact: Jose M Nieto, MD|
|Principal Investigator: Jose M Nieto, MD|
|United States, Illinois|
|NorthShore University HealthSystem||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: JoAnn Carbray|
|Principal Investigator: Michael Ujiki, MD|
|United States, Maryland|
|Johns Hopkins Medical Institution||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Vivek Kumbhari, MD|
|Contact: Jackie Lobien|
|Principal Investigator: Dilhana Badurdeen, MD|
|Sub-Investigator: Vivek Kumbhari, MD|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Contact: Thomas Hollander|
|Principal Investigator: Vladimir Kushnir, MD|
|United States, New York|
|Manhasset, New York, United States, 11030|
|Contact: Petros Benias, MD|
|Contact: Anil Vegesna|
|Principal Investigator: Larry Miller, MD|
|New York Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10021|
|Contact: Mariele Anneling|
|Contact: Qais Dawood|
|Principal Investigator: Reem Sharaiha, MD|
|Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029|
|Contact: Rebekah Dixon|
|Sub-Investigator: Nikhil Kumta, MD|
|Principal Investigator: Jerome Waye, MD|
|United States, Pennsylvania|
|Penn State Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Chad Varano|
|Principal Investigator: Abraham Levenick, MD|
|United States, Texas|
|Methodist Dallas Medical Center||Recruiting|
|Dallas, Texas, United States, 75214|
|Contact: Seema Arol|
|Principal Investigator: Prashant Kedia, M.D.|
|Principal Investigator:||Jennifer Maranki, MD||Penn State Milton S. Hershey School of Medicine|