Colorectal PolypORISENCT04886609
ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.
An observational study of Colorectal Polyp, run by Portsmouth Hospitals NHS Trust at 5 sites in 2 countries.
Trial summary
Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- ORISE gel
- Type of treatment
- Medical device
- How many people
- 133 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 25 Mar 2021to 12 Jan 2023
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing EMR or ESD at each recruiting centre who meet below eligibility criteria will be invited to participate.
Who may be able to join
- > 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites
Leeds General Infirmary
Leeds, LS1 3EX
Kings College Hospital
London, SE5 9RS
John Radcliffe Hospital
Oxford, OX3 9DU
Portsmouth Hospital NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.
Read the 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 for a successful resection (EMR/ ESD). Injection of fluid into the submucosa cushions and isolates the tissue just before capture of the target lesion with a snare, thereby reducing thermal injury and the risk of perforation during EMR. ESD requires a long period of submucosal dissection and that involves multiple injections to maintain the submucosal cushion; without which the risk of perforation increases.
A mixture of normal saline solution + epinephrine and blue dye like indigo carmine is the commonly used injecting solution. However, Saline dissipates very quickly leading to frequent and multiple injections. This leads to longer procedure time.
Studies have demonstrated long-lasting effects of colloids when injected in the submucosal space. ORISE gel is a newly licensed injecting solution which contains a poloxamer agent leading to longer lasting submucosal cushion effect.
Multicentre prospective observational cohort study
Primary Objective : Primary Objective To evaluate the technical feasibility, effectiveness \& safety of the ORISE gel as an injecting solution on its own during endoscopic resection of colorectal polyps (ability to start and finish the resection with ORISE).
Secondary Objective : To identify Polyp Resection Time (PRT) and the amount of ORISE gel used during resection of large colorectal polyps.
- Conditions
- Colorectal Polyp
- Being tested
- ORISE gel
- Keywords
- ORISE gel, EMR, ESD, Colorectal polyps, submucosal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORISE gelDevice
To establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability
Ease of use, rated on a 5-point visual analog scale for: very easy, easy, neutral, difficult and very difficult.
Measured: 1 year
Effectiveness
Number of patients where alternatives to ORISE gel had to be used to complete the procedure
Measured: 1 year
Safety - Presence of Muscle fibers in the resected specimen
Presence of Muscle fibers in the resected specimen
Measured: 1 year
Safety - Complications
Complications: Perforationpost polypectomy syndrome, Intra procedural bleeding, post procedural
Measured: 1 year
Secondary outcomes (3)
Total injected volume per lesion size
Total injected volume per lesion size: calculated by dividing the injected volume needed to complete the EMR procedure (in mL) by the lesion size (in mm2).
Measured: 1 year
Sydney Resection Quotient
Sydney Resection Quotient: calculated by dividing the lesion size (in mm2) by the number of resections required to remove the lesion
Measured: 1 year
Feasability
Polyp Resection Time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start25 Mar 2021
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Why it stopped: Safety issues/concerns with device use reported by the manufacturer and requested product recall and to stop use of product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, Prof, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886609
- Sponsor's protocol ID
- 275810
- Acronym
- ORISE
- Status last verified
- Nov 2024
- First submitted
- 10 May 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Non identifiable Data regards primary and secondary outcome measures to be shared with other investigators
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.
- ClinicalTrials.gov ID
- NCT04886609
- Acronym / sponsor ID
- ORISE / 275810
- Conditions
- Colorectal Polyp
- Keywords
- ORISE gel, EMR, ESD, Colorectal polyps, submucosal injection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Safety issues/concerns with device use reported by the manufacturer and requested product recall and to stop use of product.
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 for a successful resection (EMR/ ESD). Injection of fluid into the submucosa cushions and isolates the tissue just before capture of the target lesion with a snare, thereby reducing thermal injury and the risk of perforation during EMR. ESD requires a long period of submucosal dissection and that involves multiple injections to maintain the submucosal cushion; without which the risk of perforation increases.
A mixture of normal saline solution + epinephrine and blue dye like indigo carmine is the commonly used injecting solution. However, Saline dissipates very quickly leading to frequent and multiple injections. This leads to longer procedure time.
Studies have demonstrated long-lasting effects of colloids when injected in the submucosal space. ORISE gel is a newly licensed injecting solution which contains a poloxamer agent leading to longer lasting submucosal cushion effect.
Multicentre prospective observational cohort study
Primary Objective : Primary Objective To evaluate the technical feasibility, effectiveness \& safety of the ORISE gel as an injecting solution on its own during endoscopic resection of colorectal polyps (ability to start and finish the resection with ORISE).
Secondary Objective : To identify Polyp Resection Time (PRT) and the amount of ORISE gel used during resection of large colorectal polyps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing EMR or ESD at each recruiting centre who meet below eligibility criteria will be invited to participate.
Key inclusion criteria (3 listed)
- > 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORISE gelTo establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps | Device | – |
Primary outcome
Feasability
Time frame: 1 year
Ease of use, rated on a 5-point visual analog scale for: very easy, easy, neutral, difficult and very difficult.
Effectiveness
Time frame: 1 year
Number of patients where alternatives to ORISE gel had to be used to complete the procedure
Safety - Presence of Muscle fibers in the resected specimen
Time frame: 1 year
Presence of Muscle fibers in the resected specimen
Safety - Complications
Time frame: 1 year
Complications: Perforationpost polypectomy syndrome, Intra procedural bleeding, post procedural
3 secondary outcomes
Total injected volume per lesion size
Time frame: 1 year
Sydney Resection Quotient
Time frame: 1 year
Feasability
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Safety issues/concerns with device use reported by the manufacturer and requested product recall and to stop use of product.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Undecided. Non identifiable Data regards primary and secondary outcome measures to be shared with other investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Bhandari, Prof principal investigator
Portsmouth Hospitals NHS Trust
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyp, run by Portsmouth Hospitals NHS Trust at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Safety issues/concerns with device use reported by the manufacturer and requested product recall and to stop use of product.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.