Trial Outcomes & Findings for Chemically Assisted Capsulectomy-A New Clinical Approach (NCT NCT00758667)
NCT ID: NCT00758667
Last Updated: 2014-12-10
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
one year
Results posted on
2014-12-10
Participant Flow
Participant milestones
| Measure |
Standard
Standard procedure or capsulectomy for removal of capsule;
|
Mesna
The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemically Assisted Capsulectomy-A New Clinical Approach
Baseline characteristics by cohort
| Measure |
Standard
n=9 Participants
Standard procedure or capsulectomy for removal of capsule; no mesna
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
|
Mesna
n=11 Participants
The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearOutcome measures
| Measure |
Standard
n=9 Participants
Standard procedure or capsulectomy for removal of capsule; no mesna
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
|
Mesna
n=11 Participants
The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
|
|---|---|---|
|
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: one yearOutcome measures
| Measure |
Standard
n=9 Participants
Standard procedure or capsulectomy for removal of capsule; no mesna
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
|
Mesna
n=11 Participants
The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
|
|---|---|---|
|
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
|
0 participants
|
0 participants
|
Adverse Events
Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mesna
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place