Institutional Outcome Data From Per-oral Plication of the Esophagus

NCT ID: NCT03875365

Last Updated: 2024-04-11

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

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-02

Study Completion Date

2024-01-19

Brief Summary

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Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. This data will help researchers determine the safety and efficacy of a novel minimally invasive treatment compared to invasive surgery.

Detailed Description

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Researchers will be collecting electronic medical data for subjects who have already undergone Per-oral Plication of the Esophagus (POPE) procedure. Subject characteristics, radiographic documentation, videos, procedural details, and subject reported outcomes would be collected. This data will be used for review and analysis to answer questions aimed in this study. Data collected from this study will be entered into a database that will be maintained for future research.

Conditions

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Achalasia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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POPE Patients

Patients who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus.

POPE

Intervention Type PROCEDURE

Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure.

Interventions

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POPE

Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults \> 18 years of age
* Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure

Exclusion Criteria

* Patients \<18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shanda Blackmon

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-007834

Identifier Type: -

Identifier Source: org_study_id

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