SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

Launched by SAFEHEAL INC · Aug 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the Colovac Anastomosis Protection Device, which is designed to help protect the connection made during surgery for colorectal cancer. This device acts as a temporary internal bypass to support healing after surgery where part of the colon is removed and a temporary opening (called an ileostomy) is made to divert waste. The goal is to see if the device is safe and works well in helping patients recover after this type of surgery.

Adults aged 22 and older who are scheduled for a specific kind of colorectal cancer surgery that preserves the anal sphincter and includes a planned temporary ileostomy may be eligible to join. To participate, patients should be generally well enough for surgery and able to follow study instructions. People with certain health conditions, allergies to the device materials, or who are pregnant will not be able to join. During surgery, if complications arise like heavy bleeding or issues with the bowel, the patient may no longer qualify for the study. If you join, you can expect close monitoring before, during, and after surgery to check how the device is working and to ensure your safety. This study is not yet recruiting participants but aims to help improve recovery outcomes for people undergoing colorectal cancer surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A subject meeting all of the following criteria will be considered for participation in the study:
• • 1. Adult patients (22 years of age or older)
• • 2. Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy.
• • 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• • 4. Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
• Exclusion Criteria:
• * Preoperative:
• • 1. Active colitis
• • 2. Known allergy to nickel or other components of the Colovac system
• • 3. Pregnant or nursing female subject
• • 4. Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
• 5. 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:
• • 1. Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
• • 2. Immunodeficiency (CD4+ count \< 500 CU MM)
• • 3. Systemic and ongoing steroid therapy within the past 6 months
• • 4. Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
• • 5. 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
• • 6. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, or carcinomatosis
• • 7. Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
• • 8. Severe malnutrition defined as 10% weight loss within 3 months prior to enrollment.
• • 6. The subject is currently participating in another investigational drug or device study that may confound the results of SAFE-3CV. Prior approval from SafeHeal Medical Monitor must be obtained prior to enrollment in SAFE-3CV.
• Intraoperatively:
• 7. Occurrence of any of the following during the colorectal surgery:
• • 1. Blood loss (\>750 cc)
• • 2. Blood transfusion
• • 3. Any new sign of bowel ischemia
• • 4. Positive air leak test
• • 5. Inadequate bowel preparation
• • 6. Anastomosis location greater than 10 cm from the anal verge
• • 7. Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures