Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy

NCT00250328 | Unknown Phase 1

• 1 other identifier: HMO-CLP 52-01- HMO-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device instead of staplers. Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related to device use. The efficacy endpoint of this study includes clinical evaluation of characteristic parameters related to intestinal surgeries. Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed every day during hospitalization and in the follow up visits.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Functioning anastomosis without leaks or obstructions

Secondary Outcomes (1)

• Functioning anastomosis without stenosis

Interventions

LapCAC Laparoscopic Compression Anastomosis Clip DEVICE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age over 18 years.
• Patient schedule for colonic surgery which requires a bowel anastomosis (right colon, left colon, sigma).
• Patient is able to understand and to sign the Informed Consent Form.

You may not qualify if:

• Patient has known allergy to nickel.
• Emergency procedure, i.e. patients with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischaemic bowel, carcinomatosis.
• Patients with Crohn's disease needed more than one anastomosis.
• Patient underwent previous major abdominal surgery.
• Patients under steroid treatment.
• Patient albumin level less than 3 g/dl
• Patients under immuno-suppression or cytotoxic treatment.
• Patients who are participating in another trial which may affect the outcomes data on this study.
• Patients with contraindications to general anaesthesia.
• Patients who refuse consent.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ibrahim Matter, MD

  Benei-Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim Matter, MD

CONTACT

04-8359137; matardoc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2005
• First Posted: November 8, 2005
• Study Start: January 1, 2006
• Last Updated: November 8, 2005

Record last verified: 2005-11

Locations

IL (1)