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NCT01635374 · ClinicalTrials.gov registry record · NA
Per-Oral Endoscopic Esophagomyotomy (POEM)
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 400
- Enrollment target
NCT01635374: Completed NA study, sponsored by Northwestern University.
NCT01635374 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 400 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01635374, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
Study Summary
Achalasia is an esophageal motility disease that usually requires surgical intervention (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new NOTES based procedure, per-oral endoscopic esophagomyotomy (POEM), has been developed that eliminates the need for skin incisions. All patients enrolled in this study, will have a thorough pre-op workup (including upper endoscopy, upper GI radiographs, high resolution esophageal manometry) confirming the diagnosis of achalasis at the Northwestern Esophageal Center. In this procedure, performed in the operating room under general anesthesia, a flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin esophagram will be performed on post-op day 1 to rule out esophageal leak. All patient will have a 2-3 week post-op appointment Patients with a confirmed diagnosis of achalasia may be offered POEM. The investigators hypothesize that POEM is feasible and safe and can effectively reduce residual LES pressure (as determined by manometry) and improve patients symptoms and quality of life.
Primary Outcome
a brief 4 question survey will be filled out
Interventions
- PROCEDURE Per-Oral Endoscopic Esophagomyotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01635374 record still lists
NCT01635374 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Per-Oral Endoscopic Esophagomyotomy is the first listed.
NCT01635374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01635374 about?
NCT01635374 is a clinical study titled "Per-Oral Endoscopic Esophagomyotomy (POEM)". Achalasia is an esophageal motility disease that usually requires surgical intervention (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new NOTES based procedure, per-oral endos...
What is the current status of trial NCT01635374?
This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2010-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01635374?
The interventions under investigation include: Per-Oral Endoscopic Esophagomyotomy (PROCEDURE).
Who is sponsoring clinical trial NCT01635374?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01635374's enrollment target sits among peer trials
400 246th of 2000 higher than 1,734 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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