Nasal Compression Device Study for Epistaxis

NasaClip

Status: Enrolling

Conditions: Epistaxis Nosebleed

Treatments: Device: Nasal Compression Device; Diagnostic Test: Routine Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05789264

EMI001

Details and patient eligibility

About

This study will explore how a nasal compression device compares to manual compression for stopping anterior nosebleeds. This will be a non-randomized controlled trial enrolling participants presenting to medical care for anterior nosebleeds. Participants will be assigned to receive either a nasal compression device or standard of care consisting of digital compression. Participants will be asked to complete survey questions to assess satisfaction with the care they received, comfort, and overall experience with the device.

Full description

This will be a non-randomized controlled trial study design. Alternating assignments will be made to either the nasal compression device arm or standard of care (manual nasal compression with pinching) arm.

Patients with anterior nosebleeds and not meeting any exclusion criteria will be identified upon registration at the study locations. The patient will be approached by a study team member who will briefly inform the patient about the study and invite the patient to participate. If the patient agrees to participate, they will be assigned to either the nasal compression device arm or the standard of care arm. Participants will then undergo a brief medical screening by a medical provider during the triage process to ensure no exclusion criteria are present. A study information sheet including key information, risks and benefits, and study team contact information will be provided for the patient to review while they are receiving treatment. Patients will be allowed to end their participation in the study at any time.

Participants will then be assessed every 5-10 minutes by a study team member to evaluate if bleeding has resolved. If a participant is still bleeding during a bleeding check they will be supplied a new device/gauze to avoid having to reuse bloodied material.

If bleeding has not resolved after 30 minutes of wearing the nasal compression device or with digital pressure, this will be defined as a treatment failure and patients will receive second line therapies at the discretion of the medical provider. Participants in the device arm will be provided with a NasaClip device upon discharge from the study site and all participants will be contacted 48 hours later to determine if they had further epistaxis at home, whether they used the device if given one, ease of application at home, and whether it was successful.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Presenting with anterior epistaxis determined as someone with venous bleeding that can be controlled with external compression.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged at least 18.
4. In good general health as determined by the PI or Sub-I(s).

EXCLUSION

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Known allergic or hypersensitivity reactions to components of NasaClip or oxymetazoline.
2. Less than 18 years of age.
3. Known pregnancy.
4. Unable to provide informed consent.
5. Subjects who are prisoners or who are in police custody.
6. Identified by the medical team as having an acute exacerbation or poor control of any of the following medical conditions: high blood pressure, heart disease, thyroid disease, diabetes, trouble urinating due to an enlarged prostate.
7. Patients taking MAO inhibitors.
8. Medical instability or need for emergent intervention as determined by on-site medical team.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Participants assigned to the standard of care arm will be guided through clearing out clots in the nose (if using oxymetazoline), correct head positioning and how to appropriately hold nasal pressure and +/- oxymetazoline applied by a trained medical provider. No packing material will be inserted into the nares and only external pressure will be applied.

Treatment:

Diagnostic Test: Routine Care

Nasal Compression Device

Experimental group

Description:

Participants assigned to the nasal compression device arm will be provided with the device package which will include the compression device, nasal sponges, and +/- oxymetazoline nasal spray to apply to the sponges as well as written/graphical assembly and application instructions. Participants will then assemble and apply the device themselves under the supervision of a trained medical provider.

Treatment:

Device: Nasal Compression Device