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NCT01873300 · ClinicalTrials.gov registry record · Phase 1

Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure

A Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target

NCT01873300: Completed Phase 1 study, sponsored by Massachusetts General Hospital.

NCT01873300 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01873300, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.

Primary Outcome

Patients will be given a quality of life and dysphagia questionare before surgery and at 3 and 6 months after surgery

Interventions

  • PROCEDURE Endoscopic Esophageal Myotomy

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2012-02
Est. Completion 2014-08
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT01873300 record still lists

NCT01873300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Endoscopic Esophageal Myotomy is the first listed.

NCT01873300 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01873300 about?

NCT01873300 is a clinical study titled "Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure". Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose t...

What is the current status of trial NCT01873300?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2012-02. Estimated completion is 2014-08.

What interventions are being tested in trial NCT01873300?

The interventions under investigation include: Endoscopic Esophageal Myotomy (PROCEDURE).

Who is sponsoring clinical trial NCT01873300?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01873300's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01873300, the US trial registry maintained by the National Library of Medicine. NCT01873300 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.