Clinical Validation of C-REX Device for Adaptive Anastomoses

NCT04836676 | Unknown

• 1 other identifier: CREX-006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Adaptive anastomoses; C-REX; Colorectal cancer; Post-Market

Outcome Measures

Primary Outcomes (1)

• Incidence rate of radiologically verified clinical anastomotic leakage related to the investigational device(s).

  Anastomotic leakage is defined as a defect in the intestinal wall at the site of the anastomosis (including C-REX short-term implants) which leads to a communication between the intra- and extraluminal spaces. The severity of anastomotic leakage should be classified according to the clinically required measures. Grade A anastomosis leakage does not lead to any change in the researcher's handling, while Grade B leakage requires active therapeutic intervention but is manageable without relaparotomy. Grade C anastomotic leakage requires relaparotomy.

  Up to 30 days after surgery

Secondary Outcomes (8)

• Air leak test during surgery

  During surgery

• C-REX integrity pressure test (optional)

  During surgery

• Duration of surgery

  During surgery

• Time to evacuation of the short-term implant

  About 10 ± 2 days after surgery

• Postoperative complication assessment

  Up to 30 days after surgery

Other Outcomes (1)

• Assessment of post-operative satisfaction

  Through study process, an average of 3 months

Study Arms (1)

C-REX group

EXPERIMENTAL

After resection of the disease in colon, the intestinal ends will be anastomosed by the investigational device, i.e. C-REX LapAid Cath or C-REX RectoAid Cath.

Device: C-REX Device

Interventions

C-REX Device 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.

C-REX group

Eligibility Criteria

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

You may qualify if:

• Male or female age ≥ 18 years old.
• Planned resection due to benign or malign disease in the left colon or the rectum.
• Cognitive ability to take part in the study and understand the information the patient receives about participating in the study and provide informed consent.

You may not qualify if:

• Pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.
• Non-curable metastatic disease (cancer with multi-organ metastases).
• Intestinal or anal stenosis or other obstructions distal to the anastomotic site.
• Contraindications to general anaesthesia.

Sponsors & Collaborators

• Carponovum AB: lead
• Stockholm South General Hospital: collaborator
• Karolinska University Hospital: collaborator
• Danderyd Hospital: collaborator
• Capio Sankt Görans Hospital: collaborator
• Ersta Diakoni: collaborator

Study Sites (5)

Danderyds Sjukhus

Danderyd, Stockholm County, 18257, Sweden

Location

Capio Saint Göran's Sjukhus

Stockholm, 11219, Sweden

Location

Ersta diakoni

Stockholm, 11628, Sweden

Location

Södersjukhuset

Stockholm, 11883, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Torbjörn Holm, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Grönberg, MD, PhD

CONTACT

+46708378626; anders@carponovum.com

Study Design

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

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

SE (5)