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Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository

Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02770859
Acronym
POEM
Enrollment
5000
Registered
2016-05-12
Start date
2014-10-16
Completion date
2040-01-31
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia

Keywords

Achalasia

Brief summary

POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle & sphincter of the LES for the treatment of achalasia.

Detailed description

Achalasia is a disease of the muscle of the esophagus (food tube) & means "a failure to relax." The esophagus consists of 3 parts: the first part (uppermost part) is the upper esophageal sphincter (UES). The UES is a specialized ring of muscle which separates the esophagus from the throat, & prevents food in the second part (body) of the esophagus from regurgitating into the throat. The third part of the esophagus (lower esophageal sphincter \[LES\]) also consists of a specialized ring of muscle which separates the body of the esophagus from the stomach, & prevents food & acid from regurgitating into the body of the esophagus. When achalasia is present, patients experience dysphasia (difficulty swallowing food, & \[sometimes\] liquids), chest pain & can experience recurrent pneumonia & loss of weight. Current treatments for achalasia include oral medications (calcium channel blockers) to relax the LES (difficult to swallow pill/capsule), dilation (stretching) of the LES, (temporary relief) & Esophagomyotomy (general surgery to cut the LES). POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle & sphincter of the LES for the treatment of achalasia.

Interventions

PROCEDUREPOEM (Per Oral Endoscopic Myotomy)

Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

18 years of age Referral for the treatment of Achalasia

Exclusion criteria

Less than 18 years of age; Absence of Achalasia

Design outcomes

Primary

MeasureTime frameDescription
Improved Eckardt Score5 yearsConsists of 4 questions used to characterize the severity of achalasia. The questions include symptoms related to dysphagia, chest pain, regurgitation, and weight loss. Each question is assigned a score from 0 to 3 based on the patient's self reported response. The overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJohn M DeWitt, M.D.

Indiana University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026