Colorectal CancerPhase 2NCT00497263
End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study
A Phase 2 study testing Niti CAR in people with Colorectal Cancer and Diverticulitis, run by Niti Medical Technologies Ltd. at 1 site in Belgium.
Trial summary
the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Diverticulitis
- What is being tested?
- Niti CAR
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patient with contraindication to general anesthesia
- Patient who is currently participating in other clinical trial
- Patient who refuse consent
Trial locations and contacts
1 site in 1 country.
About this study
the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis
- Conditions
- Colorectal Cancer, Diverticulitis
- Being tested
- Niti CAR
- Medical subject headings
- Colorectal Neoplasms, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niti CARDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
functioning anastomosis & no occurrence of adverse events related to device use
Measured: during hospitalization and until 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Niti Medical Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- André D'Hoore, MD, PhD, Principal investigator, University Hospitals Gasthuisberg Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497263
- Sponsor's protocol ID
- CLP-43-01 Rev 01
- Status last verified
- Jun 2011
- First submitted
- 4 Jul 2007
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study
- ClinicalTrials.gov ID
- NCT00497263
- Acronym / sponsor ID
- CLP-43-01 Rev 01
- Conditions
- Colorectal Cancer, Diverticulitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Niti Medical Technologies Ltd.Industry (pharma, biotech, devices)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niti CAR | Device | – |
Primary outcome
functioning anastomosis & no occurrence of adverse events related to device use
Time frame: during hospitalization and until 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André D'Hoore, MD, PhD principal investigator
University Hospitals Gasthuisberg Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niti CAR in people with Colorectal Cancer and Diverticulitis, run by Niti Medical Technologies Ltd. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functioning anastomosis & no occurrence of adverse events related to device use (time frame: during hospitalization and until 3 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.