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NCT01662024 · ClinicalTrials.gov registry record · NA

Endoscopic Suturing for Primary Obesity Treatment

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT01662024: Completed NA study, sponsored by Brigham and Women's Hospital.

NCT01662024 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01662024, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

Primary Outcome

Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.

Interventions

  • DEVICE Endoscopic gastric restrictive procedure

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2013-02
Est. Completion 2016-04
Phase NA
Brigham and Women's Hospital

937 total trials

What the finished NCT01662024 record still lists

NCT01662024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Endoscopic gastric restrictive procedure is the first listed.

NCT01662024 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01662024 about?

NCT01662024 is a clinical study titled "Endoscopic Suturing for Primary Obesity Treatment". Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endolum...

What is the current status of trial NCT01662024?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-02. Estimated completion is 2016-04.

What interventions are being tested in trial NCT01662024?

The interventions under investigation include: Endoscopic gastric restrictive procedure (DEVICE).

Who is sponsoring clinical trial NCT01662024?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01662024's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01662024, the US trial registry maintained by the National Library of Medicine. NCT01662024 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.