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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03875365
Other study ID # 18-007834
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 2, 2018
Est. completion date January 19, 2024

Study information

Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date January 19, 2024
Est. primary completion date January 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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