SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study

NCT06540807 | Active Not Recruiting FDA Device

• 1 other identifier: SAFE-2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Colovac

EXPERIMENTAL

The Colovac device will be implanted for approximately 10 days.

Device: Colovac Colorectal Anastomosis Protection Device; Procedure: Stoma creation

Interventions

Colovac Colorectal Anastomosis Protection Device 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)

Also known as: Colovac 2

Colovac

Stoma creation PROCEDURE

Diverting loop ileostomy

Colovac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Blood loss (\>750 cc)

Sponsors & Collaborators

• SafeHeal Inc: lead

Study Sites (1)

AKFA

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: July 31, 2024
• Primary Completion: March 6, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)