Colorectal CancerNCT06540807
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
A study testing Colovac Colorectal Anastomosis Protection Device and Stoma creation in people with Colorectal Cancer, run by SafeHeal Inc at 1 site in Uzbekistan.
Trial summary
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colovac Colorectal Anastomosis Protection Device and Stoma creation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUzbekistan
- Study dates
- 31 Jul 2024to 26 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older
- Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2History of left sided colitis
- Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Who cannot join
- History of left sided colitis
- Known allergy to nickel or other components of the Colovac 2 System
- Pregnant or nursing female subject
- Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol described procedures or interfere with the interpretation of study results including, but not limited to:
- Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
Show all 21Show fewer
- Immunodeficiency (CD4+ count < 500 CU MM)
- Systemic steroid therapy within the past 6 months
- Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
- 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
- Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
- Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
- Severe malnutrition which is defined as at least 10% weight loss within 3 months prior to enrollment.
- Occurrence of any of the following during the colorectal surgery:
- Blood loss (>750 cc)
- Blood transfusion
- Any new sign of ischemia
- Positive air leak test
- Inadequate bowel preparation
- Anastomosis location greater than 15 cm from the anal verge
- Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study: A Study to Investigate the Performance and Safety of the Colovac 2 Colorectal Anastomosis Protection Device
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.
Read the detailed description
A primary diverting stoma is widely used by surgeons to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
Colovac is a local, temporary, minimally invasive bypass device that protects the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac allows stoma avoidance in all patients except those whose anastomosis have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.
- Conditions
- Colorectal Cancer
- Being tested
- Colovac Colorectal Anastomosis Protection Device, Stoma creation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colovac Colorectal Anastomosis Protection DeviceDevice
Also called Colovac 2
A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)
Stoma creationProcedure or surgery
Diverting loop ileostomy
| Study group | Role | What they receive |
|---|---|---|
| Colovac | Experimental | The Colovac device will be implanted for approximately 10 days. Receives: Device: Colovac Colorectal Anastomosis Protection Device; Procedure: Stoma creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration
Rate of clinically significant device migration The rate of subjects for which the device has migrated clinically significant during its 10-day implant period.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start31 Jul 2024
- Primary completion6 Mar 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- SafeHeal Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Okiljon Rahimov, MD, Principal investigator, Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology MoH of RUzNarxodja Sametdinov, MD, Principal investigator, Akfa Medline LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540807
- Sponsor's protocol ID
- SAFE-2023
- Status last verified
- May 2026
- First submitted
- 29 Jul 2024
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sylla P, Lam K, Komen N, Tuech JJ, Spinelli A, Martz J, Rhee R, Marcet J, Cadiere GB, Rouanet P, Karachun A, Denost Q, Sametdinov N, D'Hoore A, Lee S, Lefevre JH. Safety and Performance of the Colovac Anastomosis Protection Device. A Pooled Analysis of Prospective Studies Compared With Diverting Loop Ileostomy (SAFE-2025). Ann Surg. 2026 Sep 2. doi: 10.1097/SLA.0000000000007171. Online ahead of print.
PubMed 42681563Lefevre JH, Karachun A, Sametdinov N, Raximov O, Rustamov A, Adilkhodjaev A, Yunusov S, Mirzagolib T, Sylla P. Performance and safety of the Colovac 2 colorectal anastomotic protection device: the SafeHeal SAFE-2023 study. Surg Endosc. 2026 May;40(5):4126-4135. doi: 10.1007/s00464-026-12691-y. Epub 2026 Mar 5.
PubMed 41787083
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study: A Study to Investigate the Performance and Safety of the Colovac 2 Colorectal Anastomosis Protection Device
- ClinicalTrials.gov ID
- NCT06540807
- Acronym / sponsor ID
- SAFE-2023
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SafeHeal IncIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.
Detailed description
A primary diverting stoma is widely used by surgeons to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
Colovac is a local, temporary, minimally invasive bypass device that protects the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac allows stoma avoidance in all patients except those whose anastomosis have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colovac | Experimental | Device: Colovac Colorectal Anastomosis Protection Device, Procedure: Stoma creationThe Colovac device will be implanted for approximately 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2History of left sided colitis
- Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Key exclusion criteria (21 listed)
- History of left sided colitis
- Known allergy to nickel or other components of the Colovac 2 System
- Pregnant or nursing female subject
- Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol described procedures or interfere with the interpretation of study results including, but not limited to:
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 |
|---|---|---|
| Colovac Colorectal Anastomosis Protection DeviceAlso: Colovac 2A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis) | Device | Colovac |
| Stoma creationDiverting loop ileostomy | Procedure or surgery | Colovac |
Primary outcome
Migration
Time frame: 10 days
Rate of clinically significant device migration The rate of subjects for which the device has migrated clinically significant during its 10-day implant period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42681563Sylla P, Lam K, Komen N, Tuech JJ, Spinelli A, Martz J, Rhee R, Marcet J, Cadiere GB, Rouanet P, Karachun A, Denost Q, Sametdinov N, D'Hoore A, Lee S, Lefevre JH. Safety and Performance of the Colovac Anastomosis Protection Device. A Pooled Analysis of Prospective Studies Compared With Diverting Loop Ileostomy (SAFE-2025). Ann Surg. 2026 Sep 2. doi: 10.1097/SLA.0000000000007171. Online ahead of print.
- Derived from this study: PubMed 41787083Lefevre JH, Karachun A, Sametdinov N, Raximov O, Rustamov A, Adilkhodjaev A, Yunusov S, Mirzagolib T, Sylla P. Performance and safety of the Colovac 2 colorectal anastomotic protection device: the SafeHeal SAFE-2023 study. Surg Endosc. 2026 May;40(5):4126-4135. doi: 10.1007/s00464-026-12691-y. Epub 2026 Mar 5.
- 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.
Okiljon Rahimov, MD principal investigator
Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology MoH of RUz
Narxodja Sametdinov, MD principal investigator
Akfa Medline LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colovac Colorectal Anastomosis Protection Device and Stoma creation in people with Colorectal Cancer, run by SafeHeal Inc at 1 site in Uzbekistan.
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 21 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Migration (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540807, which also lists 2 linked publications.
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 20 May 2026.