SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

Official title

SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study: A Study to Evaluate Safety and Effectiveness of the Colovac Anastomosis Protection Device

Overview

Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Colorectal surgery is associated with a high risk of morbidity and mortality in comparison to other general surgery subspecialties. This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a larger scale.

Detailed description

The Colovac Anastomosis Protection Device is intended for use in patients requiring low anterior rectal anastomoses to limit stoma creation to only those patients requiring more time for anastomosis healing when the device is removed, allowing patients with a healed anastomosis to avoid stoma creation. To reduce the risk of life-threatening complications, Colovac provides an alternative to stoma creation which prevents stoma related risks, including permanent stoma.

Interventions

• Device Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer
  Subjects in the Investigational cohort (SAFE-3CV) will undergo an LAR procedure followed by Colovac placement. Colovac retrieval will then occur at \~10 days post LAR procedure.

Primary outcome measures

• Performance: Clinically meaningful ostomy avoidance rate at Day 10 [Time frame: at 10 day visit]
• Safety: Cumulative rate of Major Complications [Time frame: 9 months]

Eligibility criteria

Inclusion criteria

A subject meeting all of the following criteria will be considered for participation in the study:

• Adult patients (22 years of age or older)
• Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion criteria

• Preoperative:

• Active colitis
• Known allergy to nickel or other components of the Colovac 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 and ongoing 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, or 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 defined as 10% weight loss within 3 months prior to enrollment.
• 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:

• Occurrence of any of the following during the colorectal surgery:

• Blood loss (>750 cc)
• Blood transfusion
• Any new sign of bowel ischemia
• Positive air leak test
• Inadequate bowel preparation
• Anastomosis location greater than 10 cm from the anal verge
• Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 12 centers

• Keck Medicine of USC — Los Angeles
• Cedars-Sinai Medical Center — Los Angeles
• University of Miami — Miami
• Tampa General Hospital — Tampa
• Boston Medical Center — Boston
• University of Massachusetts — Worcester
• Maimonides Medical Center — Brooklyn
• Mount Sinai Hospital — New York
• … and 4 more centers

France · 3 centers

• Bordeaux Colorectal Institute — Bourdeaux
• Chu du Rouen — Rouen
• Hopital Saint-Antoine — Paris

Belgium · 2 centers

• UZA — Edegem
• UZ Leuven — Leuven

Italy · 1 center

• Humanitas Research Hospital — Rozzano

Publications

• Pastier C, Sylla P, Lee SW, Spinelli A, Komen N, Marks J, Martz J, Rhee R, Maykel J, Marcet J, Denost Q, Zaghiyan K, Davids JS, Paluvoi N, Hiller D, McLemore EC, Maggiori L, D'hoore A, Jafari MD, Poylin V, Buzas CJ, Tuech JJ, Lefevre JH. Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an internationa PMID 42285586

Identifiers

NCT: NCT07116668 · SAFE-3CV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗