Colorectal SurgeryNCT00867958
Compression Anastomosis Using the CAR™ 27
A study testing Compression Anastomosis Ring: CAR™ 27 in people with Colorectal Surgery, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 siteIsrael
- Study dates
- Sep 2008to Dec 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
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.
Read more
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-mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionDec 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.
- 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
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- novoGI
- Investigators
- Yakov Khromov, Dr., Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867958
- Sponsor's protocol ID
- 08-CAR-07-IL-01
- Status last verified
- May 2009
- First submitted
- 22 Mar 2009
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Anastomosis Using the CAR™ 27
- ClinicalTrials.gov ID
- NCT00867958
- Acronym / sponsor ID
- 08-CAR-07-IL-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
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- novoGI
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Mar 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-mo
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 23 Feb 2011.
Related trials for Colorectal Surgery
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Not yet recruiting
T1 Colorectal Cancer After Local Excision: Decision Between Surgery and Active Surveillance (T1LDA Trial)
Colorectal Cancer
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.
Yakov Khromov, Dr. principal investigator
haemek medical center
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 HaEmek Medical Center, Israel at 1 site in Israel.
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 23 Feb 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 Israel. 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-mo). 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 23 Feb 2011.