Institutional Outcome Data From Per-oral Plication of the Esophagus

Achalasia Clinical Trial

Official title:

Institutional Outcome Data From Per-oral Plication of the Esophagus (POPE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03875365
• Other study ID #: 18-007834
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

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