Institutional Outcome Data From Per-oral Plication of the Esophagus

Terminated

• Conditions: Achalasia
• Interventions: Procedure: POPE

• Registration Number: NCT03875365
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcomes using the CONDUIT patient questionnaire.	01/01/2017-9/17/2018	Evaluate efficacy by reviewing patient reported outcomes of the novel minimally invasive treatment compared to invasive surgery.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	01/01/2017-9/17/2018	Evaluate safety by assessment of adverse events of the novel minimally invasive treatment compared to invasive surgery.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States