NCT00497263

Brief Summary

the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

First QC Date

July 4, 2007

Last Update Submit

June 28, 2011

Conditions

Colorectal CancerDiverticulitis

Outcome Measures

Primary Outcomes (1)

  • functioning anastomosis & no occurrence of adverse events related to device use

    during hospitalization and until 3 months after discharge

Interventions

Niti CARDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age over 18
  • Patient schedule for colonic surgery requiring E-t-E anastomosis
  • Patient is able to understand and to sign the Informed Consent Form

You may not qualify if:

  • Patient has known allergy to Nickel
  • Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection
  • Patient on regular steroid medication
  • Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis
  • Patient following radiation (that compromised the anastomosis)
  • Patient who are undergoing a defunctioning stoma
  • Patient with contraindication to general anesthesia
  • Patient who is currently participating in other clinical trial
  • Patient who refuse consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Gasthuisberg Leuven

Leuven, Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Colorectal NeoplasmsDiverticulitis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDiverticular DiseasesGastroenteritis

Study Officials

  • André D'Hoore, MD, PhD

    University Hospitals Gasthuisberg Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 4, 2007

First Posted

July 6, 2007

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

BE(1)