Clinical Validation of C-REX Device for Adaptive Anastomoses

Summary

In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. A frequency of anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further.

The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts live quality of patients negatively.

Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters.

The newly developed adaptive anastomotic medical devices, C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful pre-market data support a successful CE marking of the devices, which encourages a post-market clinical follow-up (post CE mark clinical study) in patients undergoing colonic resection to collect post-market data of C-REX LapAid Cath and C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis.

Conditions

• Cancer Colonic

Interventions

DEVICE

C-REX Device

The investigational devices are C-REX LapAid Cath or C-REX RectoAid Cath. C-REX LapAid Cath consists of an invasive surgical part, i.e. anastomotic ring comprised of two LapAn coupled by DMC/DM, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine. C-REX RectoAid Cath consists of an invasive surgical part, i.e. an anastomotic ring comprised of RectoAn and LapAn, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine. C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control and validate the integrity of the anastomosis during and after surgery.

Sponsors & Collaborators

• Stockholm South General Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Danderyd Hospital

  collaborator OTHER

• Capio Sankt Görans Hospital

  collaborator OTHER

• Ersta Diakoni

  collaborator OTHER

• Carponovum AB

  lead INDUSTRY

Principal Investigators

• Torbjörn Holm, MD, PhD · Karolinska Institutet

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-30

Primary Completion

2023-04-30

Completion

2023-04-30

Countries

• Sweden

Study Locations