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Eleview<sup>®</sup> Dosing

Eleview<sup>®</sup> Dosing

Review the dosing guidelines for Eleview® submucosal injection. Also, review results from a clinical trial comparing Eleview® with normal saline, along with the study design.

Guidelines for procedures

  • Eleview® dosing should be based on the dimensions of the lesion to be removed1
  • One-to-two ampoules are generally used when resecting a colon lesion
  • During the procedure do not exceed a total dose of 50 mL per patient, either in single or in multiple administrations1

Eleview® with methylene blue ampoules

One box contains 5 ampoules with 10 mL each.

Eleview® requires significantly less volume2,3

In a clinical study, Eleview® required significantly less volume to complete the resection compared with normal saline with methylene blue. 2,3

Total injected volume needed to complete the resection2,3
(mean mL)

Total injection volume needed to complete the resection with Eleview® chart

Total injected volume needed per lesion size2,3
(mean mL/mm)

Total injection volume needed per lesion with Eleview® chart

Study design

A randomized double-blind, comparative effectiveness and safety study of EMR of large sessile polyps in the colon. See full study design

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)

Population

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

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.

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Less volume and fewer reinjections with Eleview®

Designed to require fewer reinjections2

  • Eleview® is designed to require fewer reinjections and less volume compared to normal saline2

How to order Eleview®

Box of Eleview® submucosal injection agentDiscover the multiple options for ordering Eleview® submucosal injection agent. Eleview® is available through the Aries network of distributors and third-party suppliers.

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.