Chemically Assisted Capsulectomy-A New Clinical Approach

December 8, 2014 updated by: R. Bruce Shack, Vanderbilt University
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All females undergoing capsulectomy

Exclusion Criteria:

  • All pregnant women and nursing mothers will be exclued

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard treatment
Experimental: Use of Mesna
Standard surgical procedure with Mesna
Drug: Mesna
B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Bruce Shack, MD, Vanderbit Unviersity Medical Center

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

January 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010518

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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