Study Design

Study Design

Endoscopic removal of polyps in the gastrointestinal tract

A randomized, double-blind, comparative effectiveness and safety study of Eleview® for EMR of large sessile polyps in the colon.

Principal investigators

  • Douglas K. Rex, MD, Indiana University Hospital, Indianapolis, IN (US)
  • Michael B. Wallace, MD, Mayo Clinic, Jacksonville, FL (US)
  • Prateek Sharma, MD, University of Kansas Medical Center, Kansas City, KS (US)
  • Alessandro Repici, MD, lstituto Clinico Humanitas, Milan (Italy)
  • Pradeep Bhandari, Solent Centre for Digestive Diseases, Portsmouth (UK)

Overview

A post-approval, randomized, double-blind trial comparing the effectiveness and safety of submucosal injection with Eleview® vs saline with methylene blue was performed in patients undergoing EMR of treatment-naïve polyps or adenomas of the colon > 20 mm.

Population

  • 211 patients
  • Eleview® (n =102)
  • Comparator (n=109)
  • Sites’ standard of care: A mixture of normal saline and methylene blue

population graphic

Primary endpoints

Efficacy:

  • Total injected volume needed to complete the EMR procedure
  • Total injected volume per lesion size
  • Time to resect the lesion completely

Safety:

  • Complication and adverse event occurrence during and after the procedure

Secondary endpoints were also explored.

Clinical results

Review the clinical trial detailed above comparing Eleview® with normal saline with methylene blue.
Download the paper

Eleview® clinical trial data paper

INDICATIONS FOR USE

Eleview® submucosal injectable composition is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

CONTRAINDICATIONS

Patients with known sensitivity to any of the components contained in Eleview®.

WARNINGS AND PRECAUTIONS

  • The endoscopist injecting Eleview® must be experienced in the administration technique.
  • The safety of Eleview® has not been established in pregnant or lactating women, or in children under 18 years of age.
  • Eleview® is provided in single-use ampoules. Eleview® should not be reused after the first opening. Any emulsion not injected during the procedure should not be reused for another endoscopic procedure.
  • Do not use if the primary packaging (ampoule) or secondary packaging (aluminum pouch) is damaged.
  • Do not use if the twist-off cap is damaged.
  • Do not use if the emulsion is not clear, shows any signs of opalescence, or contains floating or precipitated visible particles.
  • The product compatibility with other substances has not been tested.

ADVERSE REACTIONS

Rarely, local bleeding and/or inflammatory reaction could occur which may or may not be associated with Eleview®.

DOSAGE AND ADMINISTRATION

The administered dose of Eleview® should be determined based on the dimensions of the lesion to be removed. Inject into the submucosa the amount of Eleview® needed to form a submucosal cushion of optimal height and shape for the lesion to be removed. During the procedure do not exceed a total dose of 50 mL per patient, either in single or in multiple administrations.

Please see Instructions for Use for complete Important Safety Information.