NCT00758667

Brief Summary

The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5 years until next milestone

Results Posted

Study results publicly available

December 10, 2014

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

3.6 years

First QC Date

September 23, 2008

Results QC Date

December 23, 2013

Last Update Submit

December 8, 2014

Conditions

Implant Capsular Contracture

Keywords

capsular contracturecapsulectomymesnaCapsular contracture after breast implant placement

Outcome Measures

Primary Outcomes (1)

  • Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care

    one year

Secondary Outcomes (1)

  • Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care

    one year

Study Arms (2)

Standard treatment

NO INTERVENTION

Standard treatment

Use of Mesna

EXPERIMENTAL

Standard surgical procedure with Mesna

Drug: Mesna

Interventions

MesnaDRUG

B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed

Use of Mesna

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All females undergoing capsulectomy

You may not qualify if:

  • All pregnant women and nursing mothers will be exclued

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Implant Capsular Contracture

Interventions

Mesna

Condition Hierarchy (Ancestors)

Foreign-Body ReactionInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsProsthesis FailurePostoperative Complications

Intervention Hierarchy (Ancestors)

AlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur Acids

Results Point of Contact

Title
R. Bruce Shack, MD
Organization
Vanderbilt University
bruce.shack@vanderbilt.edu
615-936-0160

Study Officials

  • Bruce Shack, MD

    Vanderbit Unviersity Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
R. Bruce Shack, MD

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

January 1, 2005

Primary Completion

August 1, 2008

Study Completion

December 1, 2009

Last Updated

December 10, 2014

Results First Posted

December 10, 2014

Record last verified: 2014-12