Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis

May 13, 2024 updated by: Thomas D. Atwell, Mayo Clinic
To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

The purpose of this study is to characterize the recovery and symptom relief following cryoablation of abdominal wall endometriosis. Patients undergoing clinically indicated ablation of abdominal wall endometriosis will receive an endometriosis-specific symptom survey (Endometriosis Health Profile - 30) prior to ablation and then at 3-, 6-, 12-, and 24-months following treatment. A 2 question survey related to pain at the treatment site will also be administered prior to ablation and then at 1-, 7-, and 30-days after ablation.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with endometriosis of the abdomen wall.

Description

Inclusion Criteria:

  • Undergoing ablation for abdominal wall endometriosis.

Exclusion Criteria:

  • Decline to participate in research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom severity due to abdominal wall endometriosis following ablation.
Time Frame: Baseline and intermittently over 24 months
Using the Endometriosis Health Profile - 30 survey, the impact of ablation on endometriosis-related symptoms will be quantified over time. A numerical rating scale will be used to quantify pain at the site of treated abdominal wall endometriosis.
Baseline and intermittently over 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Thomas Atwell, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

May 15, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-005485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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