Status:
UNKNOWN
Clinical Validation of C-REX Device for Adaptive Anastomoses
Lead Sponsor:
Carponovum AB
Collaborating Sponsors:
Stockholm South General Hospital
Karolinska University Hospital
Conditions:
Cancer Colonic
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Detailed Description
OVERALL DESIGN: The study is a post-market multicentre non-randomized controlled study. In each investigational site, the investigational personnel shall start with colonic resections, first 10 patie...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Other conditions upon surgeon's discretion that may warrant exclusion.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04836676
Start Date
April 1 2021
End Date
April 1 2023
Last Update
April 12 2021
Active Locations (5)
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1
Danderyds Sjukhus
Danderyd, Stockholm County, Sweden, 18257
2
Capio Saint Göran's Sjukhus
Stockholm, Sweden, 11219
3
Ersta diakoni
Stockholm, Sweden, 11628
4
Södersjukhuset
Stockholm, Sweden, 11883