Rectal CancerNCT04184973
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
A study testing CG-100 intraluminal bypass device and Stoma in people with Rectal Cancer and Rectal Tumor, run by Colospan Ltd. at 10 sites in 5 countries.
Trial summary
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Rectal Cancer, Rectal Tumor, Rectal/Anal
- What is being tested?
- CG-100 intraluminal bypass device and Stoma
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 23 Jun 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 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 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
- Patient is diagnosed with colorectal cancer
- Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge
- Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
- Patient is scheduled to undergo mechanical bowel preparation
- The patient 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
- Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).
- Patients with ASA classification > 3
- 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
- Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
Show all 16Show fewer
- BMI ≥ 40
- Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.
- The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.
- Patient has been taking regular systemic/ steroid medication in the last 6 months.
- Patients is taking antimetabolites or antiplatelet agents.
- Patient has preexisting sphincter problems
- Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.
- Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
- Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
- Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Shelly Sharon, MSc contact
10 sites in 5 countries
United States6 sites, 3 recruiting
- Recruiting
Colorado University Anschutz Medical Campus
Aurora, Colorado, 80045
Nargis Kalia, 303-724-0333, nargis.kalia@cuanschutz.edu
Jon Vogel, MD
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Anna Nefcy, 3139169387, lnefcy1@hfhs.org
Craig Reickert, MD
- Active, not recruiting
University of California Irvine
Irvine, California, 92868
- Active, not recruiting
Lifespan & Brown Surgical Associates
Providence, Rhode Island, 02906
- Active, not recruiting
University of Utah Health
Salt Lake City, Utah, 84132
- Recruiting
Kaiser Permanente San Diego medical Center
San Diego, California, 92123
Mike Fechter, LVN, (858) 266 - 6604, michael.d.fechter@kp.org
Daniel Klaristenfeld, MD
Germany1 site, 1 recruiting
- Recruiting
Asklepios
Hamburg
Petra Frey, 49401818818623, p.frey@asklepios.com
Daniel MD Perez
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba, 85025
Ilia Pinsk, MD, 972-8-6400250, IliaPi@clalit.org.il
Elchanan Quint, MD, Elchananq@gmail.com
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Milan, Lombardy, 20089
Antonino Spinelli, MD, +39 02 82247776, antonino.spinelli@hunimed.eu
Annalisa Maroli, annalisa.maroli@cancercenter.humanitas.it
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne
Sandrine Geinoz, 410213146651, sandrine.geinoz@chuv.ch
Dieter MD Hahnloser
About this study
Official title: Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Read the detailed description
A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.
- Conditions
- Rectal Cancer, Rectal Tumor, Rectal/Anal
- Being tested
- CG-100 intraluminal bypass device, Stoma
- Keywords
- anastomosis, leak, mesorectal, ileostomy, colostomy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-100 intraluminal bypass deviceDevice
a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)
StomaProcedure or surgery
Primary protective ileostomy
| Study group | Role | What they receive |
|---|---|---|
| CG-100 | Experimental | Patients receive CG-100 during rectal cancer surgery Receives: Device: CG-100 intraluminal bypass device |
| SOC | Active comparator | Patients receive a protective stoma during rectal cancer surgery Receives: Procedure: Stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stoma creation rate
Measured: 39 Weeks
Incidence of complications
Measured: 39 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start23 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184973
- Sponsor's protocol ID
- CLD-075
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2019
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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
- Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
- ClinicalTrials.gov ID
- NCT04184973
- Acronym / sponsor ID
- CLD-075
- Conditions
- Rectal Cancer, Rectal Tumor, Rectal/Anal
- Keywords
- anastomosis, leak, mesorectal, ileostomy, colostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Colospan Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Dec 2019 (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.
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Detailed description
A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG-100 | Experimental | Device: CG-100 intraluminal bypass devicePatients receive CG-100 during rectal cancer surgery |
| SOC | Active comparator | Procedure: StomaPatients receive a protective stoma during rectal cancer surgery |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is willing to comply with protocol-specified follow-up evaluations
- Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
- Patient is diagnosed with colorectal cancer
- Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge
- Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
Key exclusion criteria (16 listed)
- Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).
- Patients with ASA classification > 3
- 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
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 devicea removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis) | Device | CG-100 |
| StomaPrimary protective ileostomy | Procedure or surgery | SOC |
Primary outcome
Change in Stoma creation rate
Time frame: 39 Weeks
Incidence of complications
Time frame: 39 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- U.S. Clinical Study WebsiteLink provided by the sponsor.
- 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.
Shelly Sharon, MSc contact
10 sites in 5 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 and Stoma in people with Rectal Cancer and Rectal Tumor, run by Colospan Ltd. at 10 sites in 5 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 7 inclusion and 16 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: looking for participants now, 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 10 sites in United States, Germany, Israel, Italy, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boaz Assaf (+972-9-7672518, boaz@colospan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stoma creation rate (time frame: 39 Weeks). The study lists 2 primary outcomes in all. 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.