Institutional Outcome Data From Per-oral Plication of the Esophagus

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03875365
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Anticipated Duration (Months): 50
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Procedure: POPE

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Institutional Outcome Data From Per-oral Plication of the Esophagus (POPE)
• Actual Study Start Date: Oct 2, 2018
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: POPE; Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Shanda Blackmon, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Shanda Blackmon, M.D., M.P.H., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03875365
• Other Study ID Numbers: 18-007834
• First Posted: Mar 14, 2019
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanda Blackmon, M.D., M.P.H., Principal Investigator, Mayo Clinic: POPE
• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of Jan 27, 2022