Colorectal CancerPROTECT INCT06402188
ColoSeal™ ICD System Safety and Feasibility Studies
A study testing ColoSeal ICD Device in people with Colorectal Cancer, run by Averto Medical, Inc. at 3 sites in 3 countries.
Trial summary
The studies aim to evaluate the safety and feasibility of the ColoSeal Intraluminal Colonic Diversion (ICD) System in two prospective, multicenter, single-arm studies. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ColoSeal ICD Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Jun 2023to 31 Mar 2027
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
- Subject is diagnosed with rectosigmoid or rectal cancer
- Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge).
- The subject 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).
- Subject must be willing and able to comply with study follow-up requirements.
Who cannot join
- Subject with a life expectancy < 1 year
- Subjects with ASA classification > 3
- Albumin < 30 g/liter
- Subject has local or systemic infection at the time of intervention.
- Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month of entry into this study
- Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure
Show all 24Show fewer
- Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spread inflammatory bowel disease
- 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
- Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
- BMI ≥ 40
- Subject is scheduled for a concurrent major surgical procedure during the surgery (e.g., liver resection)
- Subject has been taking regular systemic/ steroid medication in the last 3 months
- Subjects is taking antimetabolites or antiplatelet agents (with the exception of aspirin)
- Subject has undergone a prior pelvic anastomosis
- Subject requires an end-to-end anastomosis smaller than 31 mm in diameter
- Inadequate bowel preparation prior to the procedure
- Anastomotic leak detected during intraoperative leak testing
- Known allergy to any component of the device
- Known allergy to iodine or iodine-based contrast unless subject can be adequately premedicated prior to leak test
- Subject has unresolved alcohol abuse or illegal drug use
- Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation or the quality of the data
- Subject is pregnant or planning to become pregnant. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Armenia1 site, 1 recruiting
- Recruiting
National Center of Oncology after V.A. Fanarjian
Yerevan
Avetiq Petrosyan, MD, +374 10 236829, avetpetrosian@gmail.com
Georgia1 site
- Completed
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, 0112
Uzbekistan1 site, 1 recruiting
- Recruiting
National Cancer Institute
Tashkent
Hurshid Djamshidovich, MD, +998 90 997 84 89, dr.hurshid@inbox.ru
About this study
Official title: European ColoSeal™ ICD System Safety and Feasibility Study
The studies aim to evaluate the safety and feasibility of the ColoSeal Intraluminal Colonic Diversion (ICD) System in two prospective, multicenter, single-arm studies. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.
Read the detailed description
The studies aim to evaluate the safety and feasibility of the ColoSeal Intraluminal Colonic Diversion (ICD) System in two prospective, multicenter, single-arm studies conducted under identical protocols. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis. Subjects will undergo scheduled resection per the surgeon's preferred technique. Following completion of the colon anastomosis, a leak check will be performed prior to insertion of the ColoSeal ICD Device to confirm no leak is present. The ICD Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The anchor portion is positioned > 5 cm above and ideally 10-20 cm above (more proximal in GI tract) the area requiring protection from fecal flow (the anastomosis). The anchor portion of the device is designed to be placed in healthy bowel and not at the region of damaged bowel where protection is required. After positioning, deployment, and anchoring of the ICD Device the Delivery System is removed. The external portion of the device is further anchored to the subject's skin using sutures and an optional extension tubing may be attached. A collection bag is attached to the end of the device to collect output. The ICD Device will remain in place for 10+/-3 days post-operatively. An anastomosis leak test will be performed prior to device removal. Once no leak is confirmed, the ICD Device is removed from the subject.
- Conditions
- Colorectal Cancer
- Being tested
- ColoSeal ICD Device
- Keywords
- Colon anastomosis, Rectosigmoid cancer resection, Ostomy, Colon diversion
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColoSeal ICD DeviceDevice
The subject will undergo scheduled resection per the surgeon's preferred technique. Following completion of the anastomosis, the Intraluminal Colonic Diversion (ICD) Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The ICD Device will remain in place for 10±3 days. Anastomotic leak testing will be performed prior to scheduled removal.
| Study group | Role | What they receive |
|---|---|---|
| ColoSeal ICD Device Treatment Arm | Experimental | Subjects will undergo transanal placement of the ICD Device. Receives: Device: ColoSeal ICD Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with device related adverse events
Any device related adverse events during procedure and/or follow-up
Measured: 90 days post procedure
Secondary outcomes (6)
Procedure success
Rate of acute efficacy in placing and deploying the device at the desired location
Measured: Day 0
Procedure time
Time from insertion of the introducer to the vacuum system being ready to be connected and begin vacuum application
Measured: Day 0
Migration rate
Number of devices migrated over the anastomosis divided by the number of devices placed
Measured: Up to 14 days
Occurrence of anastomotic leakage
Anastomotic leak rate will be defined as any anastomotic leak during study follow-up period identified on radiographic analysis. Clinically symptomatic and non-symptomatic leaks (radiographically diagnosed only) will be analyzed separately and taken into account during comparative analysis to rates reported in literature. Anastomotic leak rate will be subdivided into those leaks occurring while device is in place in subject or late leaks after device removal.
Measured: Up to 90 days post procedure
Need for ostomy surgery
Efficacy will be determined by ostomy avoidance rate. Need for ostomy percentage will be defined as the total number of subjects that required ostomy during study follow-up period over total number of subjects enrolled who would have a planned ostomy if not a study participant.
Measured: Up to 90 days post procedure
Successful device removal
Percent of successful device removals without adverse effect
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start5 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Averto Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hurshid Djamshidovich, MD, Principal investigator, National Cancer Institute Tashkent Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402188
- Sponsor's protocol ID
- CLN0001/CLN0002
- Acronym
- PROTECT I
- Status last verified
- Oct 2026
- First submitted
- 7 May 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
- European ColoSeal™ ICD System Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT06402188
- Acronym / sponsor ID
- PROTECT I / CLN0001/CLN0002
- Conditions
- Colorectal Cancer
- Keywords
- Colon anastomosis, Rectosigmoid cancer resection, Ostomy, Colon diversion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Averto Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 May 2024 (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 studies aim to evaluate the safety and feasibility of the ColoSeal Intraluminal Colonic Diversion (ICD) System in two prospective, multicenter, single-arm studies. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.
Detailed description
The studies aim to evaluate the safety and feasibility of the ColoSeal Intraluminal Colonic Diversion (ICD) System in two prospective, multicenter, single-arm studies conducted under identical protocols. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis. Subjects will undergo scheduled resection per the surgeon's preferred technique. Following completion of the colon anastomosis, a leak check will be performed prior to insertion of the ColoSeal ICD Device to confirm no leak is present. The ICD Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The anchor portion is positioned > 5 cm above and ideally 10-20 cm above (more proximal in GI tract) the area requiring protection from fecal flow (the anastomosis). The anchor portion of the device is designed to be placed in healthy bowel and not at the region of damaged bowel where protection is required. After positioning, deployment, and anchoring of the ICD Device the Delivery System is removed. The external portion of the device is further anchored to the subject's skin using sutures and an optional extension tubing may be attached. A collection bag is attached to the end of the device to collect output. The ICD Device will remain in place for 10+/-3 days post-operatively. An anastomosis leak test will be performed prior to device removal. Once no leak is confirmed, the ICD Device is removed from the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ColoSeal ICD Device Treatment Arm | Experimental | Device: ColoSeal ICD DeviceSubjects will undergo transanal placement of the ICD Device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
- Subject is diagnosed with rectosigmoid or rectal cancer
- Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge).
- The subject 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).
- Subject must be willing and able to comply with study follow-up requirements.
Key exclusion criteria (24 listed)
- Subject with a life expectancy < 1 year
- Subjects with ASA classification > 3
- Albumin < 30 g/liter
- Subject has local or systemic infection at the time of intervention.
- Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month 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 |
|---|---|---|
| ColoSeal ICD DeviceThe subject will undergo scheduled resection per the surgeon's preferred technique. Following completion of the anastomosis, the Intraluminal Colonic Diversion (ICD) Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The ICD Device will remain in place for 10±3 days. Anastomotic leak testing will be performed prior to scheduled removal. | Device | ColoSeal ICD Device Treatment Arm |
Primary outcome
Number of participants with device related adverse events
Time frame: 90 days post procedure
Any device related adverse events during procedure and/or follow-up
6 secondary outcomes
Procedure success
Time frame: Day 0
Procedure time
Time frame: Day 0
Migration rate
Time frame: Up to 14 days
Occurrence of anastomotic leakage
Time frame: Up to 90 days post procedure
Need for ostomy surgery
Time frame: Up to 90 days post procedure
Successful device removal
Time frame: Up to 14 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.
Hurshid Djamshidovich, MD principal investigator
National Cancer Institute Tashkent Uzbekistan
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColoSeal ICD Device in people with Colorectal Cancer, run by Averto Medical, Inc. at 3 sites in 3 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 5 inclusion and 24 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 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 3 sites in Armenia, Georgia, Uzbekistan. 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 Grace Carlson, MD (1-415-518-7043, grace.carlson@avertomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with device related adverse events (time frame: 90 days post procedure). 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.