Study Stopped
Safety issues/concerns with device use reported by the manufacturer and requested product recall and to stop use of product.
ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.
ORISE
1 other identifier
observational
133
2 countries
5
Brief Summary
Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2021
CompletedFirst Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2023
CompletedNovember 14, 2024
November 1, 2024
1.8 years
May 10, 2021
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasability
Ease of use, rated on a 5-point visual analog scale for: very easy, easy, neutral, difficult and very difficult.
1 year
Effectiveness
Number of patients where alternatives to ORISE gel had to be used to complete the procedure
1 year
Safety - Presence of Muscle fibers in the resected specimen
Presence of Muscle fibers in the resected specimen
1 year
Safety - Complications
Complications: Perforationpost polypectomy syndrome, Intra procedural bleeding, post procedural
1 year
Secondary Outcomes (3)
Total injected volume per lesion size
1 year
Sydney Resection Quotient
1 year
Feasability
1 year
Interventions
To establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps
Eligibility Criteria
All patients undergoing EMR or ESD at each recruiting centre who meet below eligibility criteria will be invited to participate.
You may qualify if:
- \> 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Humaitas Research Hospital
Milan, 20089, Italy
Portsmouth Hospital NHS Trust
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Pradeep Bhandari, Prof
Portsmouth Hospitals University NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 28 Days
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 14, 2021
Study Start
March 25, 2021
Primary Completion
January 12, 2023
Study Completion
January 12, 2023
Last Updated
November 14, 2024
Record last verified: 2024-11