← Back to Search

Procedure

Per-Oral Endoscopic Myotomy (POEM) for Achalasia (POEM Trial)

N/A

Waitlist Available

Led By Steven Leeds, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient with symptomatic achalasia or EGJ outflow obstruction with a motility study, esophagram, and EGD consistent with EGJ outflow obstruction

Medical indication for surgical myotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after surgery

Awards & highlights

POEM Trial Summary

This trial tests whether the POEM procedure is an effective treatment for achalasia.

Who is the study for?

This trial is for adults aged 18-85 with swallowing disorders, specifically achalasia or EGJ outflow obstruction confirmed by medical tests. Participants must be able to undergo general anesthesia and give informed consent. It's not for those with esophageal cancer risks, strictures, Barrett's esophagus, pregnancy, previous chest radiotherapy or conditions preventing EGD.Check my eligibility

What is being tested?

The study is testing the effectiveness of Per-Oral Endoscopic Myotomy (POEM), a less invasive surgical procedure designed to improve swallowing in patients with achalasia—a condition that affects the ability of the esophagus to move food toward the stomach.See study design

What are the potential side effects?

Possible side effects from POEM may include sore throat, pain or discomfort in the chest area due to gas insufflation during surgery, infection risk at incision sites inside the mouth or throat and potential complications related to anesthesia.

POEM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a swallowing disorder due to a blockage.

Select...

I need surgery to cut muscles in my digestive tract.

Select...

I can safely be put under general anesthesia.

Select...

I am between 18 and 85 years old and can make my own medical decisions.

POEM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in swallowing

POEM Trial Design

1Treatment groups

Experimental Treatment

Group I: POEM procedureExperimental Treatment1 Intervention

Patients who underwent POEM

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

POEM

2015

N/A

~140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor

200 Previous Clinical Trials

203,401 Total Patients Enrolled

Steven Leeds, MDPrincipal InvestigatorBaylor Health Care System

2 Previous Clinical Trials

5,100 Total Patients Enrolled

Media Library

Per-Oral Endoscopic Myotomy (POEM) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02482337 — N/A

Achalasia Research Study Groups: POEM procedure

Achalasia Clinical Trial 2023: Per-Oral Endoscopic Myotomy (POEM) Highlights & Side Effects. Trial Name: NCT02482337 — N/A

Per-Oral Endoscopic Myotomy (POEM) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02482337 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I partake in this clinical investigation?

"This research project is allowing 20 persons with achalasia, aged between 18 to 85, to join. Candidacy is contingent upon potential participants meeting the criteria for laparoscopic esophageal myotomy."

Answered by AI

Is enrollment available for this investigation presently?

"Per the clinicaltrials.gov page, this trial is no longer taking in participants; although it was posted on June 1st 2014 and last updated on June 26th 2020, patient recruitment has been concluded for this particular study. Fortunately, currently 78 other similar trials are open to enrolment."

Answered by AI