Status:
ACTIVE_NOT_RECRUITING
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
Lead Sponsor:
SafeHeal Inc
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ca...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06540807
Start Date
July 31 2024
End Date
December 31 2025
Last Update
May 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AKFA
Tashkent, Uzbekistan