Rectal Cancer SurgeryNCT07429110
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
A study testing ColoSeal ICD System and Protective Diverting Ostomy in people with Rectal Cancer Surgery, run by Averto Medical, Inc. at 9 sites in 2 countries.
Trial summary
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Rectal Cancer Surgery
- What is being tested?
- ColoSeal ICD System and Protective Diverting Ostomy
- 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
- 9 sitesin 2 countries
- Study dates
- 19 Jun 2026to Dec 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.
- Subject is determined to be 'robust' as assessed via the Clinical Frailty Scale (CFS; score 1-3), the Mini-Cog (score ≥3) and either the Short Physical Performance Battery (SPPB; score ≥10) or Timed Up and Go (TUG; score <12 seconds). This inclusion applies to subjects aged 71-75 only.
- Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach).
- Subject requires the creation of a stapled anastomosis maximally 10 cm from the anal verge, and minimally with sufficient distance from the anal verge to accommodate use of an anastomotic stapler.
- Subject has been informed of the study's nature, agrees to its provisions, and has provided written informed consent, which has been approved by the appropriate Ethics Committee (EC) or Institutional Review Board (IRB).
- Subject must have a designated (lay or professional) caregiver available in the in-home setting while the ICD System is in use.
- Subject should live within ≤ 75 miles (120 km) of their study investigator's facility. If outside of this range, subjects must be willing to stay in accommodations ≤ 75 miles (120 km) of the investigator's facility for 1-day post-study device removal.
- Subject must be willing and able to comply with protocol requirements, including study follow-up visits.
Who cannot join
- Preoperative:
- Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.
- Subject with a life expectancy < 1 year due to condition other than rectal cancer.
- Subject with American Society of Anesthesiologists (ASA) classification > 3.
- Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.
- Subject had major surgical or interventional procedure within 30 days before the index procedure or planned major surgical or interventional procedure within 30 days after the index procedure.
Show all 32Show fewer
- Subject has received systemic chemotherapy or radiation to the pelvis within 30 days before the planned procedure.
- Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diffuse descending colon diverticulosis (i.e., diverticula at potential planned fixation site), diverticulitis, or inflammatory bowel disease in the descending colon.
- Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function.
- Subject has a diagnosis of coagulopathy (INR≥1.5), thrombocytopenia (platelet count <150,000/μL), or immune suppression (CD4+ T-cell count <500 cells/mm³).
- Subject has a condition resulting in significant cognitive impairment and/or functional decline, such as dementia or advanced Parkinsons disease.
- Subject has a BMI ≥ 40.
- Subject is scheduled for a concurrent major surgical procedure during the index procedure (e.g., liver resection).
- Subject has been taking regular systemic steroid medication in the last 6 months prior to the index procedure.
- Subject is taking anticoagulants, antimetabolites or antiplatelet agents (Note: low-dose aspirin therapy is permitted) within 7 days of the index procedure.
- Subject has undergone a prior pelvic anastomosis.
- Subject has fecal incontinence, involvement of the sphincter by neoplastic disease, or evidence of extensive local disease in the pelvis seen on pre-operative imaging.
- Subject is diabetic with hemoglobin A1c > 8.0% (64 mmol/mol).
- Serum albumin of < 3.0 g/dL.
- Serum prealbumin of <15mg/dL.
- Subject has a known allergy to any component of the device.
- Subject has a known allergy to iodine or iodine-based contrast unless the subject can be adequately premedicated before the leak test.
- Subject has unresolved alcohol or drug abuse, in the investigator's opinion.
- Subject is pregnant or planning to become pregnant (female subjects of childbearing potential must have a negative urinary pregnancy test ≤ 7 days before the surgical procedure).
- Subject is unable or unwilling to provide informed consent.
- Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- Intraoperative:
- Subject is not planned to receive an ostomy placement at the time of the index procedure.
- Subject's left colon (bowel) preparation on the day of surgery is deemed inadequate for ICD Device placement, as determined by the investigator.
- Subject requires an end-to-end or side-to-end anastomosis smaller than 31 mm in diameter or greater than 10cm from the anal verge.
- Subject failed intraoperative leak test.
- Subject has any condition or abnormality which, in the opinion of the investigator, may jeopardize subject safety or the quality of the study data.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Medical University of South Carolina
Charleston, South Carolina, 29402
Ohio State Medical University Center
Columbus, Ohio, 43210
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Orlando Health
Orlando, Florida, 32806
University of Utah Health
Salt Lake City, Utah, 84132
Cleveland Clinic Florida
Weston, Florida, 33331
New Zealand3 sites
University of Otago - Christchurch
Christchurch, 8011
University of Otago - Dunedin Hospital
Dunedin, 9016
Waikato Hospital
Hamilton, 3240
About this study
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.
Read the detailed description
The ColoSeal Intraluminal Colonic Diversion (ICD) System, comprised of the ICD Device and the ICD Device Delivery System, is a minimally invasive medical device designed to temporarily protect a colonic anastomosis from fecal flow. It is initially intended as a less invasive alternative to temporary protective (diverting) ostomy surgery for patients with rectal colon cancer who are undergoing colon resection with reconstruction with an anastomosis.
- Conditions
- Rectal Cancer Surgery
- Being tested
- ColoSeal ICD System, Protective Diverting Ostomy
- Keywords
- Rectal Cancer, Diverting Ostomy, Stoma, Anastomosis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColoSeal ICD SystemDevice
Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.
Protective Diverting OstomyProcedure or surgery
Subjects will undergo protective diverting ostomy placement during the index procedure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: ColoSeal ICD System |
| Control | Active comparator | Not described Receives: Procedure: Protective Diverting Ostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The composite rate of subjects with index surgery-related Major Complications for the investigational treatment arm compared to the control arm at 270 days.
Measured: 270 days
Primary Efficacy Endpoint
Freedom from ostomy creation at 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start19 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized-controlled trial with 2:1 randomization of treatment to control subjects. Treatment Arm: Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure. Control Arm: Subjects will undergo protective diverting ostomy placement during the index procedure.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Averto Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Gawlicka, PhD, MBA, Study director, Averto Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429110
- Sponsor's protocol ID
- CLN0005
- Other IDs
- 1R44CA287615-01A1
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ColoSeal™ ICD System Anastomotic Protection Pivotal Study
- ClinicalTrials.gov ID
- NCT07429110
- Acronym / sponsor ID
- CLN0005
- Conditions
- Rectal Cancer Surgery
- Keywords
- Rectal Cancer, Diverting Ostomy, Stoma, Anastomosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Averto Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Feb 2026 (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 clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.
Detailed description
The ColoSeal Intraluminal Colonic Diversion (ICD) System, comprised of the ICD Device and the ICD Device Delivery System, is a minimally invasive medical device designed to temporarily protect a colonic anastomosis from fecal flow. It is initially intended as a less invasive alternative to temporary protective (diverting) ostomy surgery for patients with rectal colon cancer who are undergoing colon resection with reconstruction with an anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized-controlled trial with 2:1 randomization of treatment to control subjects. Treatment Arm: Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure. Control Arm: Subjects will undergo protective diverting ostomy placement during the index procedure.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: ColoSeal ICD System |
| Control | Active comparator | Procedure: Protective Diverting Ostomy |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.
- Subject is determined to be 'robust' as assessed via the Clinical Frailty Scale (CFS; score 1-3), the Mini-Cog (score ≥3) and either the Short Physical Performance Battery (SPPB; score ≥10) or Timed Up and Go (TUG; score <12 seconds). This inclusion applies to subjects aged 71-75 only.
- Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach).
- Subject requires the creation of a stapled anastomosis maximally 10 cm from the anal verge, and minimally with sufficient distance from the anal verge to accommodate use of an anastomotic stapler.
- Subject has been informed of the study's nature, agrees to its provisions, and has provided written informed consent, which has been approved by the appropriate Ethics Committee (EC) or Institutional Review Board (IRB).
Key exclusion criteria (32 listed)
- Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.
- Subject with a life expectancy < 1 year due to condition other than rectal cancer.
- Subject with American Society of Anesthesiologists (ASA) classification > 3.
- Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.
- Subject had major surgical or interventional procedure within 30 days before the index procedure or planned major surgical or interventional procedure within 30 days after the index procedure.
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 |
|---|---|---|
| ColoSeal ICD SystemSubjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure. | Device | Treatment |
| Protective Diverting OstomySubjects will undergo protective diverting ostomy placement during the index procedure. | Procedure or surgery | Control |
Primary outcome
Primary Safety Endpoint
Time frame: 270 days
The composite rate of subjects with index surgery-related Major Complications for the investigational treatment arm compared to the control arm at 270 days.
Primary Efficacy Endpoint
Time frame: 30 days
Freedom from ostomy creation at 30 days.
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 13 Oct 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.
Anna Gawlicka, PhD, MBA study director
Averto Medical, Inc.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColoSeal ICD System and Protective Diverting Ostomy in people with Rectal Cancer Surgery, run by Averto Medical, Inc. at 9 sites in 2 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 8 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, New Zealand. 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?
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?
Primary Safety Endpoint (time frame: 270 days). 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 13 Oct 2026.