NCT01402518

Brief Summary

This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

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

November 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 10, 2020

Status Verified

April 1, 2018

Enrollment Period

10 years

First QC Date

July 21, 2011

Last Update Submit

March 8, 2020

Conditions

Achalasia

Keywords

achalasiamyotomyendoscopic myotomydifficulty swallowing

Outcome Measures

Primary Outcomes (1)

  • To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia

    1 year

Secondary Outcomes (1)

  • To assess the quality of life, pain, and complications of the POEM approach

    1 year

Study Arms (1)

Per-oral endoscopic myotomy

Procedure: Per-oral enodscopic myotomy

Interventions

Per-oral enodscopic myotomyPROCEDURE
Also known as: POEM
Per-oral endoscopic myotomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic with the diagnosis of achalasia will be offered participation in this study.

You may qualify if:

  • Diagnosis of achalasia
  • Age 18-75
  • Mentally competent to give informed consent
  • Scheduled to undergo a POEM procedure

You may not qualify if:

  • Pregnant women
  • Any prior surgical treatment for achalasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Esophageal AchalasiaDeglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Santiago Horgan, M.D., FACS

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 26, 2011

Study Start

November 1, 2009

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

March 10, 2020

Record last verified: 2018-04

Locations

US(1)