Back to resultsSafe Anastomosis Feasibility Study (SAFE2019)
Primary Purpose
Colorectal Cancer, Anastomosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Colovac
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring anastomosis
Eligibility Criteria
Inclusion Criteria:
- Adult patients (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.
- Willingness to comply with Clinical Investigation Plan-specific treatment and study visits and to sign a written Informed Consent Form
Exclusion Criteria:
- Preoperatively :
- Patient with inflammatory bowel disease
- 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 (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 Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:
- COVID-19 positive (active infection) based on test within 72 hours prior to surgery
- Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1
- 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 defined as 10% weight loss within 3 months prior to enrollment.
The subject is currently participating in another investigational drug or device study
- Intraoperatively :
- Anastomosis placement at more than 10cm from anal margin
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 - requiring re intervention on the anastomosis
- Inadequate bowel preparation
- Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device
Sites / Locations
- UZA
- Centre Hospitalier Universitaire St Pierre
- CHU Lille
- ICM Montpellier
- Hôpital Saint Louis
- Hôpital Saint Antoine Paris
- CHRU Strasbourg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Colovac
Arm Description
Patients receive Colovac device during colorectal surgery
Outcomes
Primary Outcome Measures
To measure the incidence of serious adverse events related to using the device
The primary endpoint will be a measurement of SAEs probably related or causaly related to the use of the investigational device, to the index surgery in this clinical trial.
Secondary Outcome Measures
To measure the number of participants with evidence of absence of feces between the sheath and the colonic wall before device retrieval
Rate of patients with evidence of absence of feces between the sheath and the colonic wall before device retrieval at 10 days:
To measure the rate of ostomy avoidance
To measure the number of participants where ostomy was avoided
To evaluate the occurrence of clinical anastomotic leakage
To measure on a scale of 1 to 5 rated by the surgeon the ease of device introduction, positioning and endoscopic retrieval
Ease of device introduction and positioning will be rated by the surgeon on a scale from 1 to 5 (1 being very easy and 5 being impossible)
Ease of endoscopic retrieval of the device will be rated by the endoscopist on a scale from 1 to 5 (1 being very easy and 5 being impossible)
To evaluate the clinically significant migration rate
To evaluate the integrity above the anchoring site during the device retrieval using endoscopy.
Mucosal appearance above the anchoring site will be evaluated endoscopically during device retrieval and classified as Normal/Inflamed, Bleeding, Ulcerated, Perforated.
To evaluate the integrity of the anchoring site during the device retrieval using endoscopy.
Mucosal appearance at the anchoring site will be evaluated endoscopically during device retrieval and classified as Normal/Inflamed, Bleeding, Ulcerated, Perforated.
To evaluate the integrity of the anastomosis before the device retrieval using fluoroscopy
Fluoroscopy with injection of contrast between the colonic wall and the sheath will be performed prior to retrieval of the Colovac+ Device in order to check for anastomotic integrity before device retrieval.
Outcome is measured with presence/absence of any contrast liquid leak through the anastomosis prior to device retrieval.
To evaluate the integrity of the anastomosis after the device retrieval using fluoroscopy
Fluoroscopy with injection of contrast per rectum will be performed immediately after retrieval of the Colovac+ Device in order to check for anastomotic integrity following device retrieval.
Outcome is measured with presence/absence of any contrast liquid leak through the anastomosis after device retrieval.
To measure the average procedure time
To measure the patient tolerability of the device using a patient questionnaire
Responses to a patient questionnaire on device acceptance, on the device handling and comfort, and on preference compared to an ostomy - utilizing the NIH's (National Institute of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) health measurement questionnaires to assess parameters like pain, bowel incontinence, constipation, diarrhea, or anxiety and social isolation, on a scale from 1 to 10 (1 being absence of difficulty and 10 being severe problems).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05180565
Brief Title
Safe Anastomosis Feasibility Study
Acronym
SAFE2019
Official Title
Safe Anastomosis Feasibility Study: a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac+ Colorectal Anastomosis Protection Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device 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, Anastomosis
Keywords
anastomosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colovac
Arm Type
Experimental
Arm Description
Patients receive Colovac device 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)
Primary Outcome Measure Information:
Title
To measure the incidence of serious adverse events related to using the device
Description
The primary endpoint will be a measurement of SAEs probably related or causaly related to the use of the investigational device, to the index surgery in this clinical trial.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To measure the number of participants with evidence of absence of feces between the sheath and the colonic wall before device retrieval
Description
Rate of patients with evidence of absence of feces between the sheath and the colonic wall before device retrieval at 10 days:
Time Frame
10 days
Title
To measure the rate of ostomy avoidance
Description
To measure the number of participants where ostomy was avoided
Time Frame
3 months
Title
To evaluate the occurrence of clinical anastomotic leakage
Time Frame
3 months
Title
To measure on a scale of 1 to 5 rated by the surgeon the ease of device introduction, positioning and endoscopic retrieval
Description
Ease of device introduction and positioning will be rated by the surgeon on a scale from 1 to 5 (1 being very easy and 5 being impossible)
Ease of endoscopic retrieval of the device will be rated by the endoscopist on a scale from 1 to 5 (1 being very easy and 5 being impossible)
Time Frame
10 days
Title
To evaluate the clinically significant migration rate
Time Frame
10 days
Title
To evaluate the integrity above the anchoring site during the device retrieval using endoscopy.
Description
Mucosal appearance above the anchoring site will be evaluated endoscopically during device retrieval and classified as Normal/Inflamed, Bleeding, Ulcerated, Perforated.
Time Frame
10 days
Title
To evaluate the integrity of the anchoring site during the device retrieval using endoscopy.
Description
Mucosal appearance at the anchoring site will be evaluated endoscopically during device retrieval and classified as Normal/Inflamed, Bleeding, Ulcerated, Perforated.
Time Frame
10 days
Title
To evaluate the integrity of the anastomosis before the device retrieval using fluoroscopy
Description
Fluoroscopy with injection of contrast between the colonic wall and the sheath will be performed prior to retrieval of the Colovac+ Device in order to check for anastomotic integrity before device retrieval.
Outcome is measured with presence/absence of any contrast liquid leak through the anastomosis prior to device retrieval.
Time Frame
10 days
Title
To evaluate the integrity of the anastomosis after the device retrieval using fluoroscopy
Description
Fluoroscopy with injection of contrast per rectum will be performed immediately after retrieval of the Colovac+ Device in order to check for anastomotic integrity following device retrieval.
Outcome is measured with presence/absence of any contrast liquid leak through the anastomosis after device retrieval.
Time Frame
10 days
Title
To measure the average procedure time
Time Frame
1 day
Title
To measure the patient tolerability of the device using a patient questionnaire
Description
Responses to a patient questionnaire on device acceptance, on the device handling and comfort, and on preference compared to an ostomy - utilizing the NIH's (National Institute of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) health measurement questionnaires to assess parameters like pain, bowel incontinence, constipation, diarrhea, or anxiety and social isolation, on a scale from 1 to 10 (1 being absence of difficulty and 10 being severe problems).
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (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.
Willingness to comply with Clinical Investigation Plan-specific treatment and study visits and to sign a written Informed Consent Form
Exclusion Criteria:
- Preoperatively :
Patient with inflammatory bowel disease
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 (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 Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:
COVID-19 positive (active infection) based on test within 72 hours prior to surgery
Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1
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 defined as 10% weight loss within 3 months prior to enrollment.
The subject is currently participating in another investigational drug or device study
Intraoperatively :
Anastomosis placement at more than 10cm from anal margin
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 - requiring re intervention on the anastomosis
Inadequate bowel preparation
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
Jérémie Lefevre
Organizational Affiliation
Hôpital Saint Antoine Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZA
City
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Centre Hospitalier Universitaire St Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
ICM Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Saint Antoine Paris
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHRU Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
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Safe Anastomosis Feasibility Study
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