SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Colovac Colorectal Anastomosis Protection Device; Procedure: Stoma creation

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uzbekistan
  • Tashkent, Uzbekistan
    • AKFA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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:

  1. Blood loss (>750 cc)
  2. Blood transfusion
  3. Any new sign of ischemia
  4. Positive air leak test
  5. Inadequate bowel preparation
  6. Anastomosis location greater than 15 cm from the anal verge
  7. Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colovac; The Colovac device will be implanted for approximately 10 days.	Device: Colovac Colorectal Anastomosis Protection Device; 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); Other Names: Colovac 2; Procedure: Stoma creation; Diverting loop ileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 days

Collaborators and Investigators

• Sponsor: SafeHeal Inc
• Investigators: Principal Investigator: Okiljon Rahimov, MD, Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology MoH of RUz; Principal Investigator: Narxodja Sametdinov, MD, Akfa Medline LLC

Publications and helpful links

General Publications

• Lefevre 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 Mar 5. doi: 10.1007/s00464-026-12691-y. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): December 26, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SAFE-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes