NCT02770859

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
167mo left

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Oct 2014Jan 2040

Study Start

First participant enrolled

October 16, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
23.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2040

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

25.3 years

First QC Date

May 10, 2016

Last Update Submit

February 16, 2026

Conditions

Achalasia

Keywords

Achalasia

Outcome Measures

Primary Outcomes (1)

  • Improved Eckardt Score

    Consists 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.

    5 years

Interventions

POEM (Per Oral Endoscopic Myotomy)PROCEDURE

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

Also known as: POEM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 18 with demonstrated symptoms of Type II or Type III achalasia.

You may qualify if:

  • years of age Referral for the treatment of Achalasia

You may not qualify if:

  • Less than 18 years of age; Absence of Achalasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

Related Publications (4)

  • DeWitt J, Stainko S, Perkins A, Rosenheck M, Al-Haddad M. Impact of prior endoscopic or surgical interventions on clinical outcomes after peroral endoscopic myotomy for achalasia. Surg Endosc. 2026 Jan;40(1):174-181. doi: 10.1007/s00464-025-12258-3. Epub 2025 Oct 6.

    PMID: 41051511DERIVED

  • Jacobs CC, Al-Haddad M, Stainko S, Perkins A, DeWitt JM. Prevalence and impact of opioid use in patients undergoing peroral endoscopic myotomy. Gastrointest Endosc. 2023 Apr;97(4):655-663.e2. doi: 10.1016/j.gie.2022.12.006. Epub 2022 Dec 9.

    PMID: 36509112DERIVED

  • DeWitt JM, Kessler WR, Wo JM, Stainko S, Perkins A, Dickason D, Al-Haddad MA, Siwiec R. Symptom Association for Gastroesophageal Reflux Disease by pH Monitoring After Peroral Endoscopic Myotomy. Am J Gastroenterol. 2022 Aug 1;117(8):1316-1319. doi: 10.14309/ajg.0000000000001801. Epub 2022 Apr 25.

    PMID: 35467562DERIVED

  • DeWitt JM, Siwiec R, Kessler WR, Wo JM, Stainko S, Picklesimer Doyle M, Perkins A, Dickason D, Al-Haddad MA. Comparison of functional lumen imaging probe and high-resolution manometry to assess response after peroral endoscopic myotomy. Gastrointest Endosc. 2022 May;95(5):855-863. doi: 10.1016/j.gie.2021.12.029. Epub 2022 Jan 1.

    PMID: 34979118DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

nephronectin

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • John M DeWitt, M.D.

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Endoscopic Ultrasound

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 12, 2016

Study Start

October 16, 2014

Primary Completion (Estimated)

January 31, 2040

Study Completion (Estimated)

January 31, 2040

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

US(1)