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Mouth device aims to keep Sore-Relief rinses where They're needed

NCT ID NCT05104268

Symptom relief Sponsor: E2Bio Life Sciences, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing a new medical device called Bocaliner in people who have painful mouth sores caused by chemotherapy or radiation. The device is held in the mouth after using medicated mouthwashes, gels, or rinses, with the goal of keeping those treatments in contact with the sores longer. The study measures changes in patient-reported pain and other mouth sore symptoms over two weeks. Participants must be 18 or older, have symptomatic chemotherapy-induced oral mucositis, and be willing to use the device for two weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bocaliner, a mouth-held device that keeps medicated rinses and gels in contact with mouth sores
What this could lead to
If it works, the device could give people with painful mouth sores from cancer treatment a simple way to get more relief from the rinses and gels they already use.
What could go wrong
This is a very early, single-center study with a small number of participants, so results may not hold up in larger trials. The device may prove uncomfortable or no better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Expected to start

Nov 2024

An estimate. Start dates often move.

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Symptomatic chemotherapy-induced oral mucositis * Need for oral topical therapy for symptomatic treatment * Absence of other chronic oral disorders * Properly obtained written informed consent * Age of 18 years or older * Patient is willing to use the Bocaliner™ device for 2 weeks * No concurrent use of medications modulating pain Exclusion Criteria: * Chronic oral conditions other than chemotherapy-induced oral mucositis * No informed consent * Age of \<18 * Inability to place the device in his/her mouth and keep it in place for at least 10 minutes due to severe oral pain, large lesions, or any other reason * Inability/unwillingness to wear Bocaliner™ for the study period * Concurrent use of pain-modulating agents * Individuals with known allergies to silicone materials * Individuals with severe difficulties to communicate and understand

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Conditions

The condition(s) this trial relates to.

disease related to hematopoietic stem cell transplant neoplasm stomatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral mucositis Stem cell transplant complications

Contacts and locations

Locations

  • Hematology Center after Prof. R. Yeolyan MH RA

    Yerevan, 0014, Armenia

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