Colorectal SurgeryNCT00880984
Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)
A study testing Compression Anastomosis Ring: CAR™ 27 in people with Colorectal Surgery, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection. Study Design: Prospective, open labeled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Compression Anastomosis Ring: CAR™ 27
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2008to Sep 2009
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is over 18 years old.
- Patient is scheduled for a non-emergency procedure.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Who cannot join
- Patient has an allergy to nickel.
- Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
- Patient is participating in another clinical trial which may affect this study's outcomes.
- Patient has been taking regular steroid medication.
- Patient has contraindications to general anesthesia.
- Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compression Anastomosis Using the CAR™ 27
Purpose:
Evaluation of the CAR™ 27 for the creation of compression anastomoses.
Read more
Indication:
Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.
Study Design:
Prospective, open labeled study.
Patient Population:
Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.
No. of Subjects:
15 patients estimated up to three months to enroll.
Duration of Treatment:
During the operation - creation of the anastomosis.
Duration of Follow-up:
Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.
Endpoints:
To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.
- Conditions
- Colorectal Surgery
- Being tested
- Compression Anastomosis Ring: CAR™ 27
- Keywords
- Colon Anastomosis, Rectum Anastomosis, Intestine, Colorectal Surgery, Colorectal Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression Anastomosis Ring: CAR™ 27Device
Also called CAR™ 27
Creation of anastomosis in colorectal surgeries using CAR™ 27
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- novoGI
- Investigators
- Spiros Papavramidis, Prof., Principal investigator, AHEPA University Hospital of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880984
- Sponsor's protocol ID
- 08-CAR-07-Gr-01
- Status last verified
- Jul 2009
- First submitted
- 13 Apr 2009
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Anastomosis Using the CAR™ 27
- ClinicalTrials.gov ID
- NCT00880984
- Acronym / sponsor ID
- 08-CAR-07-Gr-01
- Conditions
- Colorectal Surgery
- Keywords
- Colon Anastomosis, Rectum Anastomosis, Intestine, Colorectal Surgery, Colorectal Anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- novoGI
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- First posted
- 14 Apr 2009 (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.
Purpose:
Evaluation of the CAR™ 27 for the creation of compression anastomoses.
Indication:
Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.
Study Design:
Prospective, open labeled study.
Patient Population:
Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.
No. of Subjects:
15 patients estimated up to three months to enroll.
Duration of Treatment:
During the operation - creation of the anastomosis.
Duration of Follow-up:
Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.
Endpoints:
To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is over 18 years old.
- Patient is scheduled for a non-emergency procedure.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Key exclusion criteria (6 listed)
- Patient has an allergy to nickel.
- Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
- Patient is participating in another clinical trial which may affect this study's outcomes.
- Patient has been taking regular steroid medication.
- Patient has contraindications to general anesthesia.
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 |
|---|---|---|
| Compression Anastomosis Ring: CAR™ 27Also: CAR™ 27Creation of anastomosis in colorectal surgeries using CAR™ 27 | Device | – |
Primary outcome
Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc
Time frame: 3-months
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 7 Jan 2010.
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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.
Spiros Papavramidis, Prof. principal investigator
AHEPA University Hospital of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression Anastomosis Ring: CAR™ 27 in people with Colorectal Surgery, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 6 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 7 Jan 2010. 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 Greece. 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.
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?
Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc (time frame: 3-months). 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 7 Jan 2010.