ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-25

Study Completion Date

2023-01-12

Brief Summary

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Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.

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Detailed Description

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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

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Colorectal Polyp

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ORISE gel

To establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \> 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes