Avoidance of Ostomy
Primary
· 12 Months
Reduction in stoma creation rate
| Group | Value | 95% CI |
|---|---|---|
| Colovac | 7 | |
| Standard of Care | 0 |
Last reviewed · How we verify
NCT05010850: SAFE-2
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
Terminated
NA
Results posted
Last updated 3 July 2025
What this trial tests
NA trial testing Colovac in Colorectal Cancer in 18 participants. Terminated before completion.
Timeline
17 January 2022
Primary endpoint
19 January 2024
19 January 2024
19 January 2024
Quick facts
| Lead sponsor | SafeHeal Inc |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 17 January 2022 |
| Primary completion | 19 January 2024 |
| Estimated completion | 19 January 2024 |
| Sites | 16 locations across Belgium, France, United States |
Drugs / interventions tested
- Colovac
- Stoma Creation
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Rectal Cancer — all drugs for Rectal Cancer →
- Rectal Tumor — all drugs for Rectal Tumor →
- Rectal/Anal — all drugs for Rectal/Anal →
Sponsor
SafeHeal Inc
Who can join
18 and older, any sex, with Colorectal Cancer or Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety Major Complications
Primary
· 12 Months
Rate of subjects with major complications
| Group | Value | 95% CI |
|---|---|---|
| Colovac | 3 | |
| Standard of Care | 2 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Standard of Care
Serious: 7/8 (88%)
Deaths: 1/8
Colovac
Serious: 6/10 (60%)
Deaths: 0/10
Serious adverse events (10 terms)
| Reaction | System | Standard of Care | Colovac |
|---|---|---|---|
| Anastomosis Leakage | General disorders | — | — |
| General state of deterioration with dehydration, resulting in death | General disorders | — | — |
| Undernutrition with Naso Gastric Tube | Gastrointestinal disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Colon Intussusception | Gastrointestinal disorders | — | — |
| Acute Renal Failure | Renal and urinary disorders | — | — |
| Infection | Infections and infestations | — | — |
| Urinary Tract Infection | Infections and infestations | — | — |
| CRP Elevation | Infections and infestations | — | — |
| Dehydration which resolved | General disorders | — | — |
Other adverse events (21 terms — click to expand)
| Reaction | System | Standard of Care | Colovac |
|---|---|---|---|
| Nausea/vomiting | Gastrointestinal disorders | — | — |
| Abdominal/ Anal pain | Gastrointestinal disorders | — | — |
| Anastomosis leakage | Gastrointestinal disorders | — | — |
| Cholestasis | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Haematuria | Blood and lymphatic system disorders | — | — |
| Heart Failure | Cardiac disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Incisional hernia | Surgical and medical procedures | — | — |
| Infection of incision/surgery wound on left side | Surgical and medical procedures | — | — |
| Inflammation of skin around the anus | Gastrointestinal disorders | — | — |
| Nerve Tissue Injury | Skin and subcutaneous tissue disorders | — | — |
| Other - Denutrition | Metabolism and nutrition disorders | — | — |
| Other - Epigastric Pain | Gastrointestinal disorders | — | — |
| Other - Lymphopenia to Xeloda | Blood and lymphatic system disorders | — | — |
| Other - Polyneuropathie | Nervous system disorders | — | — |
| Other - Renal Failure | Endocrine disorders | — | — |
| Other - Worsening Hernia Inguinalis | Gastrointestinal disorders | — | — |
| Parastomal hernia | Gastrointestinal disorders | — | — |
| Urinary Infection | Endocrine disorders | — | — |
Most-reported serious reactions: Anastomosis Leakage, General state of deterioration with dehydration, resulting in death, Undernutrition with Naso Gastric Tube, Ileus, Colon Intussusception, Acute Renal Failure, Infection, Urinary Tract Infection.
Data from ClinicalTrials.gov NCT05010850 adverse events section.
Sponsor's own description
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.
Hain E, Lefèvre JH, Ricardo A, Lee S, et al · · 2024 · cited 2× · PMID 38750621 · DOI 10.1111/codi.17012 -
Taming colonic anastomotic leakage: Wisdom from the ancient Chinese legend of Yu the Great.
Jing C, Liu K. · · 2025 · PMID 41479723 · DOI 10.4240/wjgs.v17.i12.113423 -
Advanced innovations in reducing anastomotic leak: a review of emerging biomaterial applications in colorectal surgery.
Chen E, Chen L, Zhang W, Zhou W. · · 2025 · PMID 41051406 · DOI 10.1007/s00384-025-04930-w
Verify or expand the search:
- PubMed search for NCT05010850
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Colovac
Trials testing the same drug.
- NCT05180565 — Safe Anastomosis Feasibility Study · NA · completed
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Other SafeHeal Inc trials
Trials by the same sponsor.
- NCT06540807 — SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study · NA · active not recruiting
- NCT05180565 — Safe Anastomosis Feasibility Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05010850 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SafeHeal Inc
- Last refreshed: 3 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05010850.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing