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SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study (SAFE-2)

Primary Purpose

Colorectal Cancer, Rectal Cancer, Rectal Tumor

Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Colovac
Stoma Creation
Sponsored by
SafeHeal Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring anastomosis, leak, colorectal, ileostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients (greater than 18 years of age)
  2. Eligible to undergo open or minimally invasive sphincter-preserving lower anterior resection (anastomosis within 10 cm of the anal verge) with planned diverting loop ileostomy for malignant indication, assessed by a multi-disciplinary team.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  4. Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria:

  1. History of left colitis
  2. Known allergy to nickel or other components of the Colovac kit
  3. Pregnant or nursing female subject
  4. Concomitant major surgical procedure in combination with Colorectal resection (e.g.. 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. COVID-19 positive (active infection) based on test within 48 hours prior to surgery
    2. Immunodeficiency (CD4+ count < 500 mm3)
    3. Systemic 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, 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

  7. Occurrence of any of the following during the colorectal surgery:

    1. Blood loss (>750 cc)
    2. Blood transfusion
    3. Any new sign of ischemia
    4. Positive air leak test - requiring re intervention on the anastomosis
    5. Inadequate bowel preparation
    6. Anastomosis location greater than 10 cm from the anal verge
    7. Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device

Sites / Locations

  • Kaiser Permanente - Los Angeles
  • USC Keck Hospital
  • Cedars-Sinai Medical Center
  • Tampa General Hospital
  • UMass Memorial Medical Center
  • Dartmouth-Hitchcock
  • Maimonides Medical Center
  • Mount Sinai Hospital
  • Lenox Hill Hospital
  • Lankenau Medical Center
  • Universitair Ziekenhuis Antwerpen
  • Hôpital Saint Antoine Paris
  • CHU de Besancon
  • ICM Val d'Aurelle
  • Hopital Saint-Louis
  • CHU Rouen Normandie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Colovac

Standard of Care

Arm Description

Patients receive Colovac during colorectal surgery

Patients receive the standard of care, a protective stoma, during colorectal surgery

Outcomes

Primary Outcome Measures

Avoidance of ostomy
Reduction in stoma creation rate
Safety Major Complications
Rate of subjects with major complications

Secondary Outcome Measures

Full Information

First Posted
August 11, 2021
Last Updated
January 20, 2023
Sponsor
SafeHeal Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05010850
Brief Title
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
Acronym
SAFE-2
Official Title
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Voluntary and temporary suspension of enrollment.
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SafeHeal Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
Detailed Description
A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. Colovac is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
Keywords
anastomosis, leak, colorectal, ileostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colovac
Arm Type
Experimental
Arm Description
Patients receive Colovac during colorectal surgery
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Patients receive the standard of care, a protective stoma, during colorectal surgery
Intervention Type
Device
Intervention Name(s)
Colovac
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Stoma Creation
Intervention Description
Protective ileostomy
Primary Outcome Measure Information:
Title
Avoidance of ostomy
Description
Reduction in stoma creation rate
Time Frame
12 Months
Title
Safety Major Complications
Description
Rate of subjects with major complications
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (greater than 18 years of age) Eligible to undergo open or minimally invasive sphincter-preserving lower anterior resection (anastomosis within 10 cm of the anal verge) with planned diverting loop ileostomy for malignant indication, assessed by a multi-disciplinary team. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form Exclusion Criteria: History of left colitis Known allergy to nickel or other components of the Colovac kit Pregnant or nursing female subject Concomitant major surgical procedure in combination with Colorectal resection (e.g.. 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: COVID-19 positive (active infection) if test required by hospital Immunodeficiency (CD4+ count < 500 mm3) 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 defined as ≥ 10% weight loss within 3 months prior to enrollment Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease The subject is currently participating in another investigational drug or device study 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 10 cm from the anal verge Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Sylla, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremie Lefevre, MD, PhD
Organizational Affiliation
Hopital Saint Antoine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
USC Keck Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Dartmouth-Hitchcock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Hôpital Saint Antoine Paris
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75571
Country
France
Facility Name
CHU de Besancon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
ICM Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Rouen Normandie
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study

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