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OpenTrials
Completed

NCT Number: NCT03776188

Endoscopic Suturing (ES) Registry

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

American Gastroenterological Association

Other

Collaborators

  • Apollo Endosurgery, Inc.

Registry information

Official study title

Prospective Registry for Trans-Orifice Endoscopic Suturing Applications

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2018
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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