Institutional Outcome Data From Per-oral Plication of the Esophagus

NCT03875365 | Terminated

• 1 other identifier: 18-007834
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Achalasia

Keywords

POPE

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

POPE PROCEDURE

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

POPE Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus.

You may qualify if:

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

You may not qualify if:

• Patients \<18 years of age

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

1-palmitoyl-2-oleoylphosphatidylethanolamine

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Shanda Blackmon

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: March 14, 2019
• Study Start: October 2, 2018
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-03

Locations

US (3)