Implant Capsular ContractureNCT00758667
Chemically Assisted Capsulectomy-A New Clinical Approach
A study testing Mesna in people with Implant Capsular Contracture, run by Vanderbilt University.
Trial summary
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Implant Capsular Contracture
- What is being tested?
- Mesna
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All females undergoing capsulectomy
Who cannot join
- All pregnant women and nursing mothers will be exclued
About this study
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
Read the 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.
- Conditions
- Implant Capsular Contracture
- Being tested
- Mesna
- Keywords
- capsular contracture, capsulectomy, mesna, Capsular contracture after breast implant placement
- Medical subject headings
- Implant Capsular Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesnaDrug
- Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | Standard treatment |
| Use of Mesna | Experimental | Standard surgical procedure with Mesna Receives: Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
Measured: one year
Secondary outcomes (1)
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionDec 2009
Why it stopped: preliminary analysis showed no difference
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Implant Capsular ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Bruce Shack, Vanderbilt University
- Investigators
- Bruce Shack, MD, Principal investigator, Vanderbit Unviersity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758667
- Sponsor's protocol ID
- 010518
- Status last verified
- Dec 2014
- First submitted
- 23 Sep 2008
- Last updated
- 10 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemically Assisted Capsulectomy-A New Clinical Approach
- ClinicalTrials.gov ID
- NCT00758667
- Acronym / sponsor ID
- 010518
- Conditions
- Implant Capsular Contracture
- Keywords
- capsular contracture, capsulectomy, mesna, Capsular contracture after breast implant placement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: preliminary analysis showed no difference
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 10 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –Standard treatment |
| Use of Mesna | Experimental | Drug: MesnaStandard surgical procedure with Mesna |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All females undergoing capsulectomy
Key exclusion criteria (1 listed)
- All pregnant women and nursing mothers will be exclued
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesnaB. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed | Drug | Use of Mesna |
Primary outcome
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
Time frame: one year
1 secondary outcome
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Implant Capsular Contracture
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
Recruiting
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
RecruitingObservational study
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
Capsular Contracture of Breast Implant
Recruiting
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Breast Cancer, Capsular Contracture Associated With Breast Implant
Enrolling by invitation
Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants
Postoperative Seroma Rate, Drainage Tube Removal Time, and Capsular Contracture Rate, Seroma Following Procedure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Shack, MD principal investigator
Vanderbit Unviersity Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Mesna in people with Implant Capsular Contracture, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.