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Study of a New Medical Device for Oral Mucositis

NCT05104268 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-02-20

No results posted yet for this study

Summary

This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment. The goal of this study is to determine tolerance and response to the use of Bocaliner™ as reported by patients with chemotherapy and/or radiation therapy-induced oral mucositis.

Conditions

  • Oral Mucositis
  • Stem Cell Transplant Complications

Interventions

DEVICE

Bocaliner

Bocaliner is an orally inserted device that is held within the mouth following the administration of mouthwashes, gels, and rinses that are used to treat pain associated with oral mucositis, and to reduce inflammation and to accelerate healing of oral mucositis.

Sponsors & Collaborators

  • Hematology Center after Prof. R. Yeolyan

    collaborator UNKNOWN

  • E2Bio Life Sciences, LLC

    lead INDUSTRY

Principal Investigators

  • Yervand Hakoban, MD PhD · Hematology Center after Prof. R. Yeolyan, MH RA

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-05-15
Completion
2025-12-31
FDA Device
Yes

Countries

  • Armenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05104268 on ClinicalTrials.gov