- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00758667
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
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
|
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
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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