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CompletedNCT00497263Updated Jun 29, 2011

End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study

A Phase 2 interventional study of Niti CAR in Colorectal Cancer and Diverticulitis, sponsored by Niti Medical Technologies Ltd.. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-29.

Sponsored by Niti Medical Technologies Ltd. · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Colorectal Cancer
  • Diverticulitis

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03

In context

Diverticulitis

146 studies on the registry are indexed under Diverticulitis; 26 are open to participants now.

Browse Diverticulitis studies →

Lead sponsor

Niti Medical Technologies Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DeviceNiti CAR
06

What researchers measure

Primary outcomes

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

    Time frame: during hospitalization and until 3 months after discharge

07

Study locations

1 site
  • University Hospitals Gasthuisberg Leuven
    Leuven, Brabant 3000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00497263
Lead sponsor
Niti Medical Technologies Ltd.
First posted
Jul 6, 2007
Last update
Jun 29, 2011

Study contacts

André D'Hoore, MD, PhD
principal investigator · University Hospitals Gasthuisberg Leuven

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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