← Back to Search

Group Gel ORISE for Gastric Cancer (EPSILON Trial)

N/A

Waitlist Available

Led By Arnaud Lemmers, MD,PhD

Research Sponsored by Erasme University Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from icf signature up to 2-3 weeks follow-up

Awards & highlights

EPSILON Trial Summary

This trial is testing whether a new injection gel is better than the standard glycerol injection for a specific population with superficial gastric and rectal neoplastic lesions.

Eligible Conditions

Colorectal Adenomas
Gastric Cancer

EPSILON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from icf signature up to 2-3 weeks follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from icf signature up to 2-3 weeks follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from icf signature up to 2-3 weeks follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Increase the dissection speed of the ESD procedure

Secondary outcome measures

Total procedure duration

Other outcome measures

Adverse events

Amount of submucosal solution

Clear visualisation of the plane of dissection during ESD (scale).

+10 more

EPSILON Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group Gel ORISEActive Control2 Interventions

Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Group II: Group GlycerolPlacebo Group2 Interventions

Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Erasme University HospitalLead Sponsor

195 Previous Clinical Trials

82,477 Total Patients Enrolled

Arnaud Lemmers, MD,PhDPrincipal InvestigatorErasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium

1 Previous Clinical Trials

284 Total Patients Enrolled

Media Library

Endoscopic submucosal dissection Clinical Trial Eligibility Overview. Trial Name: NCT04977401 — N/A

Gastric Cancer Research Study Groups: Group Glycerol, Group Gel ORISE

Gastric Cancer Clinical Trial 2023: Endoscopic submucosal dissection Highlights & Side Effects. Trial Name: NCT04977401 — N/A

Endoscopic submucosal dissection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04977401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participation in this research endeavor?

"Per the data found on clinicaltrials.gov, this trial is not actively looking for participants at present time. Initial postings began July 1st 2021 with a final update posted on July 22nd of the same year. However, there are still 527 medical trials seeking candidates presently."

Answered by AI

Recent research and studies

EndoscopyJournal

Update on the paris classification of superficial neoplastic lesions in the digestive tract

Endoscopic Classification Review Group. 2005. “Update on the paris classification of superficial neoplastic lesions in the digestive tract”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/s-2005-861352.

GastroenterologyJournal

Validation of a Simple Classification System for Endoscopic Diagnosis of Small Colorectal Polyps Using Narrow-band Imaging

Hewett, David G., Tonya Kaltenbach, Yasushi Sano, Shinji Tanaka, Brian P. Saunders, Thierry Ponchon, Roy Soetikno, and Douglas K. Rex. 2012. “Validation of a Simple Classification System for Endoscopic Diagnosis of Small Colorectal Polyps Using Narrow-band Imaging”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2012.05.006.

Digestive EndoscopyJournal

Narrow-band Imaging (NBI) Magnifying Endoscopic Classification of Colorectal Tumors Proposed by the Japan NBI Expert Team

Sano, Yasushi, Shinji Tanaka, Shin-ei Kudo, Shoichi Saito, Takahisa Matsuda, Yoshiki Wada, Takahiro Fujii, et al.. 2016. “Narrow-band Imaging (NBI) Magnifying Endoscopic Classification of Colorectal Tumors Proposed by the Japan NBI Expert Team”. Digestive Endoscopy. Wiley. doi:10.1111/den.12644.

EndoscopyJournal