Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

NCT00527644 | Terminated Results

• 1 other identifier: 1090979
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative day one to check for biliary leaks.

Conditions

Healthy

Keywords

biliary leaks after laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.

  By post op day one HIDA scan.

Secondary Outcomes (1)

• Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security.

  By post op day one HIDA scan.

Study Arms (1)

Spring Clips

OTHER

Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.

Device: 5mm spring clip

Interventions

5mm spring clip DEVICE

Microline Pentax 5mm Visu-Loc Clip Applier

Also known as: Visu-Loc Clip Applier, FDA Regulation Number: 21 CFR 878.4300, FDA Regulation Name: Implantable Clip, FDA Regulatory Class: II

Spring Clips

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult(18 or older)
• Diagnosis of cholelithiasis or cholecystitis
• Diagnosis of choledocholithiasis or biliary dyskinesia
• scheduled fo laparoscopic cholecystectomy
• Females: NOT pregnant

You may not qualify if:

• Breastfeeding
• Malignancy
• Inflammatory bowel disease (IBD)
• Ulcerative colitis (UC)
• Receiving steroids
• Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder
• History of connective tissue disorder

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

Limitations and Caveats

Study was terminated before expected enrollment was reached due to insufficient funds.

Results Point of Contact

• Title: Bruce Ramshaw, M.D.
• Organization: University of Missouri Health Care

kadysj@health.missouri.edu

5738841925

Study Officials

• Bruce Ramshaw, MD

  Chief, Division of General Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 6, 2017
• Results First Posted: December 6, 2017

Record last verified: 2017-11

Locations

US (1)