Colorectal CancerSH-SOC23NCT06152276
SafeHeal Diverting Ileostomy Pivotal Study
An observational study of Colorectal Cancer and Stoma Ileostomy, run by SafeHeal Inc at 22 sites in 4 countries.
Trial summary
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Stoma Ileostomy
- What is being tested?
- Diverting loop ileostomy
- How many people
- 132 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 1 Jan 2024to 30 Jan 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer undergoing low anterior resection following by a diverting loop ileostomy.
Who may be able to join
- Adult patients (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 ≤ 2
- Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Who cannot join
- Preoperative
- History of left colitis
- Known allergy to nickel or other components of the Colovac System (not applicable for control cohort)
- 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:
Show all 24Show fewer
- Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
- 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, or 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 defined as 10% weight loss within 3 months prior to enrollment.
- The subject is currently participating in another investigational drug or device study
- Intraoperatively:
- Occurrence of any of the following during the colorectal surgery:
- Blood loss (>750 cc)
- Blood transfusion
- Any new sign of bowel ischemia
- Positive air leak test
- Inadequate bowel preparation
- Anastomosis location greater than 10 cm from the anal verge
- Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States15 sites
Boston Medical Center
Boston, Massachusetts, 02118
Maimonides Medical Center
Brooklyn, New York, 11219
Northwestern University
Chicago, Illinois, 60611
Kaiser Permanente - Los Angeles
Los Angeles, California, 90027
Keck Medicine of USC
Los Angeles, California, 90033
USC Keck Hospital
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33146
Mount Sinai Hospital
New York, New York, 10029
New York Presbyterian Cornell
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Tampa General Hospital
Tampa, Florida, 33606
Novant Health
Winston-Salem, North Carolina, 27103
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
France4 sites
Bordeaux Colorectal Institute
Bourdeaux, New Aquitaine, 33000
Hopital Saint-Louis
Paris, 75010
Hôpital Saint Antoine Paris
Paris, 75012
Chu du Rouen
Rouen, Normandy, 76031
Belgium2 sites
UZA
Edegem, Antwerp, 2650
UZ Leuven
Leuven, Flemish Brabant, 3000
About this study
Official title: SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.
Read the detailed description
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.
The data from this study could serve as the historical control arm data of a SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-3) Pivotal Study designed as a prospective, non-randomized, sequential, controlled, multicenter trial comparing the investigational device, the next generation Colovac Anastomosis Protection Device, to the standard of care (SOC), diverting ostomy.
- Conditions
- Colorectal Cancer, Stoma Ileostomy
- Being tested
- Diverting loop ileostomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diverting loop ileostomyOther
Diverting loop ileostomy following low anterior resection of colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Arm | Diverting loop ileostomy following low anterior resection of colorectal cancer Receives: Other: Diverting loop ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early anastomotic complications
Early anastomotic complications
Measured: 9 months
Overall major complications
Major complications
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- SafeHeal Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Sylla, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152276
- Sponsor's protocol ID
- SH-SOC23
- Acronym
- SH-SOC23
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is confidential and only available upon a reasonable request.
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 42681563Pastier C, Sylla P, Lee SW, Spinelli A, Komen N, Marks J, Martz J, Rhee R, Maykel J, Marcet J, Denost Q, Zaghiyan K, Davids JS, Paluvoi N, Hiller D, McLemore EC, Maggiori L, D'hoore A, Jafari MD, Poylin V, Buzas CJ, Tuech JJ, Lefevre JH. Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3). BMJ Open Gastroenterol. 2026 Jun 12;13(1):e002235. doi: 10.1136/bmjgast-2025-002235.
PubMed 42285586
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)
- ClinicalTrials.gov ID
- NCT06152276
- Acronym / sponsor ID
- SH-SOC23 / SH-SOC23
- Conditions
- Colorectal Cancer, Stoma Ileostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- SafeHeal IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 30 Nov 2023 (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.
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.
Detailed description
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.
The data from this study could serve as the historical control arm data of a SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-3) Pivotal Study designed as a prospective, non-randomized, sequential, controlled, multicenter trial comparing the investigational device, the next generation Colovac Anastomosis Protection Device, to the standard of care (SOC), diverting ostomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | – | Other: Diverting loop ileostomyDiverting loop ileostomy following low anterior resection of colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer undergoing low anterior resection following by a diverting loop ileostomy.
Key inclusion criteria (4 listed)
- Adult patients (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 ≤ 2
- Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Key exclusion criteria (24 listed)
- Preoperative
- History of left colitis
- Known allergy to nickel or other components of the Colovac System (not applicable for control cohort)
- Pregnant or nursing female subject
- Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
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 |
|---|---|---|
| Diverting loop ileostomyDiverting loop ileostomy following low anterior resection of colorectal cancer | Other | Standard of Care Arm |
Primary outcome
Early anastomotic complications
Time frame: 9 months
Early anastomotic complications
Overall major complications
Time frame: 9 months
Major complications
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 4 May 2026.
- 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 42285586Pastier C, Sylla P, Lee SW, Spinelli A, Komen N, Marks J, Martz J, Rhee R, Maykel J, Marcet J, Denost Q, Zaghiyan K, Davids JS, Paluvoi N, Hiller D, McLemore EC, Maggiori L, D'hoore A, Jafari MD, Poylin V, Buzas CJ, Tuech JJ, Lefevre JH. Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3). BMJ Open Gastroenterol. 2026 Jun 12;13(1):e002235. doi: 10.1136/bmjgast-2025-002235.
- Individual participant dataSharing planned: No. The data is confidential and only available upon a reasonable request.
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
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.
Patricia Sylla, MD principal investigator
Icahn School of Medicine at Mount Sinai
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Stoma Ileostomy, run by SafeHeal Inc at 22 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 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: finished, as of the sponsor's last update on 4 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 22 sites in United States, France, Belgium, Italy. 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?
Early anastomotic complications (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT06152276, 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 4 May 2026.