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

Last updated: November 12, 2024
Sponsor: Portsmouth Hospitals NHS Trust
Overall Status: Terminated

Phase

N/A

Condition

Polyps

Treatment

ORISE gel

Clinical Study ID

NCT04886609
275810
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Lesions less than 20 mm in largest dimension

  • Subjects with ulcerated depressed lesions (Paris type III-excavated) or biopsyproven invasive carcinoma

  • Scarred polyps

  • Endoscopic appearance of deep invasive malignancy

  • Previous partial resection or attempted resection

Study Design

Total Participants: 133
Treatment Group(s): 1
Primary Treatment: ORISE gel
Phase:
Study Start date:
March 25, 2021
Estimated Completion Date:
January 12, 2023

Study 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.

Connect with a study center

  • Humaitas Research Hospital

    Milan, 20089
    Italy

    Site Not Available

  • Portsmouth Hospital NHS Trust

    Portsmouth, Hampshire PO6 3LY
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

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