Per-Oral Endoscopic Myotomy

NCT ID: NCT01402518

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Achalasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Per-oral endoscopic myotomy

Per-oral enodscopic myotomy

Intervention Type PROCEDURE

Interventions

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Per-oral enodscopic myotomy

Intervention Type PROCEDURE

Other Intervention Names

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POEM

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of achalasia
2. Age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a POEM procedure

Exclusion:

1. Pregnant women
2. Any prior surgical treatment for achalasia
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Santiago Horgan

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Santiago Horgan, M.D., FACS

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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091170, 150261

Identifier Type: -

Identifier Source: org_study_id

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