NCT03776188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 7, 2021

Status Verified

December 1, 2021

Enrollment Period

3.1 years

First QC Date

November 3, 2018

Last Update Submit

December 6, 2021

Conditions

Surgery

Keywords

Endoscopic SuturingBariatric RevisionStent FixationBariatric Surgery

Outcome Measures

Primary Outcomes (8)

  • Dislocation of Stent - distance

    Change in the position measured using distance (centimeters).

    Change at 2 weeks, 30 days, 3 months

  • Dislocation of Stent - location

    Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter

    Change at 2 weeks, 30 days, 3 months

  • Migration Rate of Stent - placement

    Distal from placement over time (yes or no)

    Change at 2 weeks, 30 days, 3 months

  • Migration Rate of Stent - replaced

    Stent replaced or re-structured over time (yes or no)

    Change at 2 weeks, 30 days, 3 months

  • Migration Rate of Stent - sutures

    Number of intact Sutures

    Change at 2 weeks, 30 days, 3 months

  • Migration Rate of Stent - removal

    Days to removal and replacement

    Change at 2 weeks, 30 days, 3 months

  • Excess Weight Loss

    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.

    Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months

  • Total Weight Loss

    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.

    Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months

Study Arms (1)

no groups - observational study

no groups - observational study

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with a condition that can be treated with trans-orifice endoscopic surgery.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Arkansas

Little Rock, Arkansas, 72211, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Borland Grover Clinic

Jacksonville, Florida, 32256, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Johns Hopkins Medical Institution

Baltimore, Maryland, 21224, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75214, United States

Location

Study Officials

  • Jennifer Maranki, MD

    Penn State Milton S. Hershey School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2018

First Posted

December 14, 2018

Study Start

October 29, 2018

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

December 7, 2021

Record last verified: 2021-12

Locations

US(11)