What is the Purpose of this Study?
The purpose of this study is to evaluate the safety and effectiveness of the Colovac device in patients undergoing colon cancer removal surgery that preserves the sphincter (muscle that relaxes or tightens to open or close the anus). This procedure is called sphincter-preserving low anterior resection for colorectal cancer. The experimental Colovac device is intended to reduce the need for a temporary diverting ileostomy, a standard procedure to protect the surgical connection in the bowel.
The Colovac device consists of 2 elements; one is placed in the colon, and the other is placed outside of the rectum and is connected to the colon using tubes. Results from this study may help people undergoing colorectal surgery in the future by helping doctors learn how to protect a surgical connection and possibly avoiding the creation of a stoma (surgically created opening that diverts waste from the body), as well the need for a second surgery to reverse the stoma.
Eligibility
- 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.
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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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Study to Evaluate Safety and Effectiveness of the Colovac Anastomosis Protection Device