Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.

NCT03423485 | Unknown DMC

• 1 other identifier: CLD-017
• Study Type: interventional
• Target: 137
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)

Conditions

Colorectal Surgery

Keywords

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic)

  Leak proof seal with at least 85% success at balloon-Mucosa interface as evidenced by contrast through the device lumen without extravasation and no illumination of the anastomosis.

  device removal day (10 days +/-1)

Secondary Outcomes (6)

• To assess the safety profile of the CG-100 Intraluminal Bypass Device.

  During surgical procedure and up to 30 days (+/- 5) ]

• To evaluate Performance in terms of clinical anastomotic leakage based on clinical symptoms of the patient such as fever, blood tests.

  Device deployment until device removal day (10 days +/-1)

• Successful positioning and maintenance of device position

  10+1 days post-surgery before device removal

• To assess the ease of the device's application and removal

  Surgical procedure and Device removal day (10 days +/-1)

• To assess the safety profile of the CG-100 Intraluminal Bypass Device.

  Up to 30 (+/- 5) days

Study Arms (1)

Study arm

EXPERIMENTAL

Anastomosis is performed according to Standard of Care with the addition of the CG-100 Intraluminal Bypass Device

Device: CG-100 Intraluminal Bypass Device

Interventions

CG-100 Intraluminal Bypass Device DEVICE

Intended to reduce contact of fecal content with an anastomotic site , following colorectal surgery.

Study arm

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is willing to comply with protocol-specified follow-up evaluations
• Patient 22-75 years of age at screening
• The patient is scheduled to undergo an elective colorectal surgery (open, laparoscopic, or robotic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
• The patient or legally authorized representative, 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).

You may not qualify if:

• Preoperative
• Pregnant or nursing female subjects. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
• Patient surgical treatment is acute (not elective)
• Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
• 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
• Patients with ASA classification \> 3
• Albumin \< 30 g/liter
• Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
• BMI ≥ 40
• Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
• Patient is participating in another clinical trial within 30 days of screening
• Patient has been taking regular steroid medication in the last 6 months.
• Patient has contraindications to general anesthesia
• Patient has preexisting sphincter problems
• Patient has evidence of extensive local disease in the pelvis

Sponsors & Collaborators

• Colospan Ltd.: lead

Study Sites (5)

Hospital Beaujon

Paris, Clichy, 92110, France

RECRUITING

University Hospital of Hamburg

Hamburg, Germany

RECRUITING

Soroka Medical Center

Beersheba, 85025, Israel

RECRUITING

Carmel Medical Center

Haifa, Israel

RECRUITING

CHUV, University Hospital Vaudois

Lausanne, Switzerland

RECRUITING

Study Officials

• Ilia Pinsk, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilia Pinsk, MD

CONTACT

+972-8-6400561; IliaPi@clalit.org.il

Avi Sechef, MD

CONTACT

+972-8-6400561; ReshefAv@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: February 6, 2018
• Study Start: January 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 31, 2019
• Last Updated: October 4, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); IL (2); CH (1); DE (1)