Colorectal SurgeryNCT03423485
Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.
A study testing CG-100 Intraluminal Bypass Device in people with Colorectal Surgery, run by Colospan Ltd. at 5 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 22 to 75 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- CG-100 Intraluminal Bypass Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Jan 2018to 15 Dec 2018
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is willing to comply with protocol-specified follow-up evaluations
- Patient 22-75 years of age at screening
- The patient is scheduled to undergo an elective colorectal surgery (open, laparoscopic, or robotic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
- The patient or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
Who cannot join
- Preoperative
- Pregnant or nursing female subjects. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
- Patient surgical treatment is acute (not elective)
- Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- 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 classification > 3
Show all 20Show fewer
- Albumin < 30 g/liter
- Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
- BMI ≥ 40
- Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
- Patient is participating in another clinical trial within 30 days of screening
- Patient has been taking regular steroid medication in the last 6 months.
- Patient has contraindications to general anesthesia
- Patient has preexisting sphincter problems
- Patient has evidence of extensive local disease in the pelvis
- Any condition which in the opinion of the investigator may jeopardize the patient's safe participation Intraoperative (prior to device deployment)
- Anastomosis is located more than 20 cm from the anal verge
- Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
- Blood loss (> 500 cc)
- Anastomosis was not performed for any reason other than consequences as a result of use of the study device -
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Israel2 sites
Soroka Medical Center
Beersheba, 85025
Carmel Medical Center
Haifa
About this study
Official title: A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety and Performance Profile of the CG-100 Intraluminal Bypass Device 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)
Read the detailed description
Colospan is initiating a pivotal clinical prospective, multi-center, single-arm, open-label study designed to evaluate safety and performance profile of the CG-100 Intraluminal Bypass Device in patients undergoing colorectal surgery study.
Up to 137 patients (in total) will be enrolled in up to 12 sites in Europe, Israel and USA.
Study objectives Primary Objective: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) Secondary Objectives: To evaluate Performance in terms of clinical and radiological anastomotic leakage Successful positioning and maintenance of device position To assess the ease of the device's application and removal Safety: To assess the safety profile of the CG-100 Intraluminal Bypass Device.
- Conditions
- Colorectal Surgery
- Being tested
- CG-100 Intraluminal Bypass Device
- Keywords
- Colorectal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-100 Intraluminal Bypass DeviceDevice
Intended to reduce contact of fecal content with an anastomotic site , following colorectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Anastomosis is performed according to Standard of Care with the addition of the CG-100 Intraluminal Bypass Device Receives: Device: CG-100 Intraluminal Bypass Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic)
Leak proof seal with at least 85% success at balloon-Mucosa interface as evidenced by contrast through the device lumen without extravasation and no illumination of the anastomosis.
Measured: device removal day (10 days +/-1)
Secondary outcomes (6)
To assess the safety profile of the CG-100 Intraluminal Bypass Device.
Rate of adverse events
Measured: During surgical procedure and up to 30 days (+/- 5) ]
To evaluate Performance in terms of clinical anastomotic leakage based on clinical symptoms of the patient such as fever, blood tests.
The patient will be followed for 10±1 days to assess the occurrence of clinical anastomotic leakage based on positive clinical symptoms of the patient such as fever, blood tests, while the CG-100 Intraluminal Bypass Device is in situ.
In addition, at 10±1 days a rectal contrast enema will be done to assess the occurrence of radiological anastomotic leakage.
Measured: Device deployment until device removal day (10 days +/-1)
Successful positioning and maintenance of device position
Position of internal sheath during rectal contrast enema based on radiological demonstration
Measured: 10+1 days post-surgery before device removal
To assess the ease of the device's application and removal
Assessment of the ease of the device's application will be done using a Device application use questionnaire completed by the surgeon at Procedure Day. The ease of device removal will also be assessed on Discharge Day, using the Device application use questionnaire
Measured: Surgical procedure and Device removal day (10 days +/-1)
To assess the safety profile of the CG-100 Intraluminal Bypass Device.
Rate of device related complications
Measured: Up to 30 (+/- 5) days
To assess the occurrence of radiological anastomotic leakage, evaluated by performing a rectal contrast enema .
At 10±1 days a rectal contrast enema will be done to assess the occurrence of radiological anastomotic leakage.
Measured: At 10±1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Jan 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilia Pinsk, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423485
- Sponsor's protocol ID
- CLD-017
- Status last verified
- Jul 2026
- First submitted
- 21 Dec 2017
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. 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 and Performance Profile of the CG-100 Intraluminal Bypass Device in Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03423485
- Acronym / sponsor ID
- CLD-017
- Conditions
- Colorectal Surgery
- Keywords
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Colospan Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 6 Feb 2018 (actual)
- 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)
Detailed description
Colospan is initiating a pivotal clinical prospective, multi-center, single-arm, open-label study designed to evaluate safety and performance profile of the CG-100 Intraluminal Bypass Device in patients undergoing colorectal surgery study.
Up to 137 patients (in total) will be enrolled in up to 12 sites in Europe, Israel and USA.
Study objectives Primary Objective: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) Secondary Objectives: To evaluate Performance in terms of clinical and radiological anastomotic leakage Successful positioning and maintenance of device position To assess the ease of the device's application and removal Safety: To assess the safety profile of the CG-100 Intraluminal Bypass Device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: CG-100 Intraluminal Bypass DeviceAnastomosis is performed according to Standard of Care with the addition of the CG-100 Intraluminal Bypass Device |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is willing to comply with protocol-specified follow-up evaluations
- Patient 22-75 years of age at screening
- The patient is scheduled to undergo an elective colorectal surgery (open, laparoscopic, or robotic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
- The patient or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
Key exclusion criteria (20 listed)
- Preoperative
- Pregnant or nursing female subjects. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
- Patient surgical treatment is acute (not elective)
- Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- 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
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 Intraluminal Bypass DeviceIntended to reduce contact of fecal content with an anastomotic site , following colorectal surgery. | Device | Study arm |
Primary outcome
To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic)
Time frame: device removal day (10 days +/-1)
Leak proof seal with at least 85% success at balloon-Mucosa interface as evidenced by contrast through the device lumen without extravasation and no illumination of the anastomosis.
6 secondary outcomes
To assess the safety profile of the CG-100 Intraluminal Bypass Device.
Time frame: During surgical procedure and up to 30 days (+/- 5) ]
To evaluate Performance in terms of clinical anastomotic leakage based on clinical symptoms of the patient such as fever, blood tests.
Time frame: Device deployment until device removal day (10 days +/-1)
Successful positioning and maintenance of device position
Time frame: 10+1 days post-surgery before device removal
To assess the ease of the device's application and removal
Time frame: Surgical procedure and Device removal day (10 days +/-1)
To assess the safety profile of the CG-100 Intraluminal Bypass Device.
Time frame: Up to 30 (+/- 5) days
To assess the occurrence of radiological anastomotic leakage, evaluated by performing a rectal contrast enema .
Time frame: At 10±1 days
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ilia Pinsk, MD principal investigator
Soroka University Medical Center
5 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 Intraluminal Bypass Device in people with Colorectal Surgery, run by Colospan Ltd. at 5 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 4 inclusion and 20 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, France, Germany, Switzerland. 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?
To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) (time frame: device removal day (10 days +/-1)). 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 6 Jul 2026.