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Trial record 1 of 1 for:    NCT03776188
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Endoscopic Suturing (ES) Registry

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ClinicalTrials.gov Identifier: NCT03776188
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
Apollo Endosurgery, Inc.
Information provided by (Responsible Party):
American Gastroenterological Association

Brief Summary:

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
Surgery

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 310 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort
no groups - observational study
no groups - observational study



Primary Outcome Measures :
  1. Dislocation of Stent - distance [ Time Frame: Change at 2 weeks, 30 days, 3 months ]
    Change in the position measured using distance (centimeters).

  2. 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

  3. Migration Rate of Stent - placement [ Time Frame: Change at 2 weeks, 30 days, 3 months ]
    Distal from placement over time (yes or no)

  4. 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)

  5. Migration Rate of Stent - sutures [ Time Frame: Change at 2 weeks, 30 days, 3 months ]
    Number of intact Sutures

  6. Migration Rate of Stent - removal [ Time Frame: Change at 2 weeks, 30 days, 3 months ]
    Days to removal and replacement

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults with a condition that can be treated with trans-orifice endoscopic surgery.
Criteria

Inclusion Criteria:

  1. Selected to undergo trans-orifice suturing prior to study enrollment
  2. Age 18+ years
  3. Patient ASA classification I, II, III, including emergency cases
  4. Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment

Exclusion Criteria:

  1. Patients who do not meet the clinical criteria for trans-orifice suturing
  2. Under age 18 years
  3. ASA classification IV
  4. Unable to provide informed consent
  5. Unable to participate in follow-up assessments
  6. Uncorrectable coagulopathy at the time of endoscopic suturing
  7. Any terminal disease that limits patient's survival to less than one year

Information from the National Library of Medicine

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


Contacts
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Contact: Sonya M Serra, MSc 3019412616 sserra@gastro.org
Contact: Yanina Nersesova, MA 3019412600 ynersesova@gastro.org

Locations
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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
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Thomas Hollander         
Principal Investigator: Vladimir Kushnir, MD         
United States, New York
Northwell Health Recruiting
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.         
Sponsors and Collaborators
American Gastroenterological Association
Apollo Endosurgery, Inc.
Investigators
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Principal Investigator: Jennifer Maranki, MD Penn State Milton S. Hershey School of Medicine
Additional Information:

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Responsible Party: American Gastroenterological Association
ClinicalTrials.gov Identifier: NCT03776188    
Other Study ID Numbers: ES Registry 2-682-101
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by American Gastroenterological Association:
Endoscopic Suturing
Bariatric Revision
Stent Fixation
Bariatric Surgery