Status:
TERMINATED
ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.
Lead Sponsor:
Portsmouth Hospitals NHS Trust
Conditions:
Colorectal Polyp
Eligibility:
All Genders
18+ years
Brief Summary
Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.
Detailed Description
Endoscopic resection of large colonic polyps is preferred over Surgical resections due to lower morbidity and preservation of the colon and its functions. The use of submucosal injection is essential...
Eligibility Criteria
Inclusion
- \> 18 years old at the date of consent
- Subjects referred for EMR for the excision of:
- Treatment naïve, laterally spreading sessile, flat polyps or adenomas of the colon equal to or greater than 20 mm in largest dimension, assessed by the investigator to be suitable for EMR or ESD.
Exclusion
- Lesions less than 20 mm in largest dimension
- Subjects with ulcerated depressed lesions (Paris type III-excavated) or biopsy proven invasive carcinoma
- Scarred polyps
- Endoscopic appearance of deep invasive malignancy
- Previous partial resection or attempted resection
Key Trial Info
Start Date :
March 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 12 2023
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04886609
Start Date
March 25 2021
End Date
January 12 2023
Last Update
November 14 2024
Active Locations (5)
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1
Humaitas Research Hospital
Milan, Italy, 20089
2
Portsmouth Hospital NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
3
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
4
Kings College Hospital
London, United Kingdom, SE5 9RS