Trial Outcomes & Findings for Clinical Evaluation of Spring-Type Laparoscopic Clip Technology (NCT NCT00527644)
NCT ID: NCT00527644
Last Updated: 2017-12-06
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
By post op day one HIDA scan.
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
Spring Clips
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
Baseline characteristics by cohort
| Measure |
Spring Clips
n=14 Participants
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier
|
|---|---|
|
Age, Customized
> 18 years
|
14 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: By post op day one HIDA scan.Outcome measures
| Measure |
Spring Clips
n=14 Participants
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier
|
|---|---|
|
No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.
|
14 Participants
|
SECONDARY outcome
Timeframe: By post op day one HIDA scan.Population: Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Spring Clips
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