Trial Outcomes & Findings for Endoscopic Suturing System for Tissue Apposition (NCT NCT00495222)
NCT ID: NCT00495222
Last Updated: 2009-09-10
Results Overview
completion of plication (1-3 knotting elements placed per procedure)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
intra-operative
Results posted on
2009-09-10
Participant Flow
Participant milestones
| Measure |
Tissue Plication
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endoscopic Suturing System for Tissue Apposition
Baseline characteristics by cohort
| Measure |
Tissue Plication
n=9 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
35.5 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: intra-operativePopulation: Intent to Treat
completion of plication (1-3 knotting elements placed per procedure)
Outcome measures
| Measure |
Tissue Plication
n=9 Participants
|
|---|---|
|
Knotting Elements Placed
|
11 elements
|
Adverse Events
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