NCT02073578

Brief Summary

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

February 24, 2014

Last Update Submit

September 21, 2021

Conditions

Achalasia

Keywords

achalasiaPOEMperoral endoscopic myotomymyotomyHeller myotomy

Outcome Measures

Primary Outcomes (2)

  • Safety and Efficacy of POEM Procedure

    To assess adverse events related to POEM

    Intraoperative to one year follow-up

  • Long-term patient-reported quality of life

    To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.

    Baseline to one year follow-up

Study Arms (1)

Treatment

OTHER

Peroral Endoscopic Myotomy (POEM)

Procedure: Peroral Endoscopic Myotomy (POEM)

Interventions

Peroral Endoscopic Myotomy (POEM)PROCEDURE

Endoscopy myotomy for treatment of achalasia

Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Achalasia
  • Age 16-80
  • ASA Class 1-3

You may not qualify if:

  • Pregnancy
  • Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.
  • Patients who are taking immunosuppressive medications or are immunocompromised
  • Patients on anticoagulant medications or abnormal coagulation tests
  • Patients with severe medical comorbidities, in the judgment of the treating surgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Kyle M Perry, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 27, 2014

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

September 27, 2021

Record last verified: 2021-09

Locations

US(1)