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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

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ClinicalTrials.gov Identifier: NCT00527644
Recruitment Status : Terminated (Insufficient funding to complete study)
First Posted : September 11, 2007
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Healthy
Intervention: Device: 5mm spring clip

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Spring Clips
STARTED   14 
COMPLETED   14 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
   Spring Clips 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age, Customized 
[Units: Participants]
Count of Participants
 
> 18 years   14 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
 
Unknown   14 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures

1.  Primary:   No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.   [ Time Frame: By post op day one HIDA scan. ]

2.  Secondary:   Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security.   [ Time Frame: By post op day one HIDA scan. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated before expected enrollment was reached due to insufficient funds.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bruce Ramshaw, M.D.
Organization: University of Missouri Health Care
phone: 5738841925
e-mail: kadysj@health.missouri.edu



Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00527644     History of Changes
Other Study ID Numbers: 1090979
First Submitted: September 7, 2007
First Posted: September 11, 2007
Results First Submitted: October 24, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017