Gastrointestinal AnastomosisNCT02109991
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
A study testing CG-100 device in people with Gastrointestinal Anastomosis, run by Colospan Ltd. at 8 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Anastomosis
- What is being tested?
- CG-100 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Mar 2014to Oct 2017
- 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
- The patient is scheduled to undergo an elective colorectal surgery (open or laparoscopic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
- The patient is willing to comply with protocol-specified follow-up evaluations
- The patient signed Informed Consent
Who cannot join
- Pregnant or nursing female subjects
- Patient surgical treatment is acute (not elective)
- Patient has infections at the time of intervention
- Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
- Patients with ASA (American Society of Anesthesiologists) classification > 3
- diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
Show all 14Show fewer
- Patient is participating in another clinical trial within 30 days of screening
- Patient has been taking regular steroid medication in the last 6 months
- Contraindications to general anesthesia
- Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis
- Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
- Blood loss (> 500 cc)
- Leak test failure during surgery
- Any condition or surgical incidence where the device deployment can jeopardize the patient's safety or interferes with study outcome per the discretion of the investigator
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Israel3 sites
Soroka Medical Center
Beersheba, 85025
Rabin Medical Center
Petah Tikva, 49100
Assuta Medical Center
Tel Aviv, 69710
Hungary2 sites
Jahn Ferenc Hospital
Budapest, 1204
National Institute of Oncology
Budapest, H-112
About this study
Official title: A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
- Conditions
- Gastrointestinal Anastomosis
- Being tested
- CG-100 device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-100 deviceDevice
Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site
| Study group | Role | What they receive |
|---|---|---|
| CG-100 device | Experimental | Not described Receives: Device: CG-100 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events, and device related complications
Measured: During surgical procedure and up to 30 days (+/- 5)
Secondary outcomes (4)
Occurrence of anastomotic leakage when the CG-100 is used
Measured: Up until device removal day (10 days +/-1)
Position of the device (internal sheath)
Measured: Device removal day (10 days +/-1)
Assessment of the device's application technique ease of placement and extraction of the device performance
Measured: Device removal day (10 days +/-1)
Determine subject tolerability of the device
Measured: Device removal day (10 days +/- 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal AnastomosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109991
- Sponsor's protocol ID
- CLD-001
- Status last verified
- Jul 2017
- First submitted
- 8 Apr 2014
- Last updated
- 8 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02109991
- Acronym / sponsor ID
- CLD-001
- Conditions
- Gastrointestinal Anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Colospan Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 10 Apr 2014 (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 CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CG-100 device | Experimental | Device: CG-100 device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is scheduled to undergo an elective colorectal surgery (open or laparoscopic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
- The patient is willing to comply with protocol-specified follow-up evaluations
- The patient signed Informed Consent
Key exclusion criteria (14 listed)
- Pregnant or nursing female subjects
- Patient surgical treatment is acute (not elective)
- Patient has infections at the time of intervention
- Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
- Patients with ASA (American Society of Anesthesiologists) classification > 3
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 |
|---|---|---|
| CG-100 deviceColorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site | Device | CG-100 device |
Primary outcome
Rate of adverse events, and device related complications
Time frame: During surgical procedure and up to 30 days (+/- 5)
4 secondary outcomes
Occurrence of anastomotic leakage when the CG-100 is used
Time frame: Up until device removal day (10 days +/-1)
Position of the device (internal sheath)
Time frame: Device removal day (10 days +/-1)
Assessment of the device's application technique ease of placement and extraction of the device performance
Time frame: Device removal day (10 days +/-1)
Determine subject tolerability of the device
Time frame: Device removal day (10 days +/- 1)
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 8 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CG-100 device in people with Gastrointestinal Anastomosis, run by Colospan Ltd. at 8 sites in 4 countries.
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 14 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel, Belgium, Hungary, Croatia. 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?
Rate of adverse events, and device related complications (time frame: During surgical procedure and up to 30 days (+/- 5)). 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 8 Dec 2017.