A Study Establishing a Registry for Endoscopic Suturing (ES)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 18-010969
    NCT ID: NCT03776188
    Sponsor Protocol Number: ES Registry 2-682-101

About this study

The purpose of this study is 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 effectiveness, 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Selected to undergo trans-orifice suturing prior to study enrollment .
  • Age 18+ years old.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Victoria Gomez, M.D.

Open for enrollment

Contact information:

Frances Cayer CCRP

(904)953-7778

Cayer.Frances@mayo.edu

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CLS-20454551

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