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Efficacy and Safety of the CG-100 Intraluminal Bypass Device

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ClinicalTrials.gov Identifier: NCT04184973
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Colospan Ltd.

Brief Summary:
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.

Condition or disease Intervention/treatment Phase
Rectal Cancer Rectal Tumor Rectal/Anal Device: CG-100 intraluminal bypass device Procedure: Stoma Not Applicable

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. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.

CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: CG-100
Patients receive CG-100 during rectal cancer surgery
Device: CG-100 intraluminal bypass device
a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)

Active Comparator: SOC
Patients receive a protective stoma during rectal cancer surgery
Procedure: Stoma
Primary protective ileostomy




Primary Outcome Measures :
  1. Change in Stoma creation rate [ Time Frame: 39 Weeks ]
  2. Incidence of complications [ Time Frame: 39 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is willing to comply with protocol-specified follow-up evaluations
  2. Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
  3. Patient is diagnosed with colorectal cancer
  4. Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge
  5. Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
  6. Patient is scheduled to undergo mechanical bowel preparation
  7. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).

Exclusion Criteria:

  1. Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
  2. Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).
  3. Patients with ASA classification > 3
  4. Albumin < 30 g/liter
  5. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
  6. Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
  7. BMI ≥ 40
  8. Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.
  9. The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.
  10. Patient has been taking regular systemic/ steroid medication in the last 6 months.
  11. Patients is taking antimetabolites or antiplatelet agents.
  12. Patient has preexisting sphincter problems
  13. Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.
  14. Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
  15. Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
  16. Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184973


Contacts
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Contact: Jonathan Elsner, PhD, MBA 617-855-5566 jonathan@colospan.com
Contact: Orit Katzir, MSc orit@colospan.com

Locations
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United States, California
University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Jasmine Balangue    714-509-2948    balanguj@hs.uci.edu   
Principal Investigator: Joseph Carmichael, MD         
United States, Colorado
Colorado University Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Andrea Pina    303-724-7803    andrea.pinalimones@cuanschutz.edu   
Contact: Micaela Galloway    (303) 724-2755    Micaela.galloway@cuanschutz.edu   
Principal Investigator: Jon Vogel, MD         
Sub-Investigator: Elisa Birnbaum, MD         
Sub-Investigator: Brandon Chapman, MD         
Sub-Investigator: Martin McCarter, MD         
United States, Florida
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Kayla Woods    407-303-2800 ext 1103878    kayla.woods@adventhealth.com   
Principal Investigator: John Monson, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Laura Trachtenberg    502-852-1671    laura.trachtenberg@louisville.edu   
Principal Investigator: Susan Galandiuk, MD         
Sub-Investigator: Russell Farmer, MD         
Sub-Investigator: Tyler Elliss, MD         
Sub-Investigator: Jeffrey Jorden, MD         
Sub-Investigator: Sandra Kavalukas, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Alana Johnson       AJohns60@hfhs.org   
Principal Investigator: Craig Reickert, MD         
Sub-Investigator: Shawn Webb, MD         
Sub-Investigator: Surya Nalamati, MD         
Sub-Investigator: Megumi Asai, MD         
Sub-Investigator: Amalia Stefanou, MD         
Sub-Investigator: Edwin Itenberg, MD         
United States, Minnesota
East Bank Hospital - M Health Fairview University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Shannon Jannatpour       sjannatp@umn.edu   
Contact: Dave Ankarlo    612-626-2498    anka0004@umn.edu   
Principal Investigator: Wolfgang Gaertner, MD         
Sub-Investigator: Cyrus Jahansouz, MD         
Sub-Investigator: Elliot Arsoniadis, MD         
Sub-Investigator: Genevieve Melton-Meaux, MD         
Sub-Investigator: Robert Madoff, MD         
United States, New York
New York-Presbyterian / Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Koianka Ivanova, PhD    646-962-2342    kivanova@med.cornell.edu   
Principal Investigator: Alessio Pigazzi, MD         
Sub-Investigator: Lea Lowenfeld, MD         
Sub-Investigator: Kelly Garrett, MD         
Sub-Investigator: Jeffrey Milson, MD         
Sub-Investigator: Parul Shukla, MD         
Sub-Investigator: Heather Yeo, MD         
United States, Rhode Island
Lifespan & Brown Surgical Associates Recruiting
Providence, Rhode Island, United States, 02906
Contact: Melanie Salerno    401-444-7148    melanie.salerno@brownphysicians.org   
Principal Investigator: Steven Schechter, MD         
Sub-Investigator: Adam Klipfel, MD         
United States, Utah
University of Utah Health Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Suzy Slomiak, CCRP    801-213-1223    Suzy.Slomiak@hsc.utah.edu   
Principal Investigator: Bartley Pickron, MD         
Sub-Investigator: Julio Cesar Delgado, MD         
Sub-Investigator: Jessica Cohan, MD         
Sub-Investigator: Lyen Camille Huang, MD         
Israel
Soroka University Medical Center Recruiting
Be'er Sheva, Israel, 85025
Contact: Ilia Pinsk, MD    972-8-6400250    IliaPi@clalit.org.il   
Contact: Elchanan Quint, MD       Elchananq@gmail.com   
Carmel Medical Center Recruiting
Haifa, Israel, 8250490
Contact: Wisam Khoury, MD    +972-4-8250490    WisamK@clalit.org.il   
Contact: Dganit Sivan       dganitsi@clalit.org.il   
Rabin Medical Center Recruiting
Petah tikva, Israel, 49100
Contact: Nir Wasserberg, MD    +972-3-9376202    nirw@clalit.org.il   
Italy
Humanitas Research Hospital Recruiting
Milano, Lombardy, Italy, 20089
Contact: Antonino Spinelli, MD    +39 02 82247776    antonino.spinelli@hunimed.eu   
Contact: Annalisa Maroli       annalisa.maroli@cancercenter.humanitas.it   
Sponsors and Collaborators
Colospan Ltd.
Additional Information:
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Responsible Party: Colospan Ltd.
ClinicalTrials.gov Identifier: NCT04184973    
Other Study ID Numbers: CLD-075
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Colospan Ltd.:
anastomosis
leak
mesorectal
ileostomy
colostomy
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases