Recruiting

Nasal Compression Device

Sponsor:

NasaClip

Code:

NCT05789264

Conditions

Epistaxis Nosebleed

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nasal Compression Device

Routine Care

Study Details

Brief summary:

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.

Conditions

Epistaxis Nosebleed

Study ID

NCT05789264

Start date

Sep 26, 2023

Status verified date

Nov, 2023

Completion date

Jun, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

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.

experimental: Nasal Compression Device

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.

Interventions

Nasal Compression Device

Participants assigned to the NasaClip arm will not receive routine care as the objective of this study is to compare the NasaClip device to routine digital compression in terms of feasibility, comfort, and efficacy. Limited data previously discussed in the background section indicates that application of nasal compression devices may be superior to digital compression.

Routine Care

Most first aid instructions for epistaxis management tell patients to apply firm digital pressure for 10 to 20 minutes, use a topical vasoconstrictor and apply an ice pack over the nose.

Primary outcome measure

  • Primary Outcome - Change over time from full epistaxis to cessation. [ Time Frame: Checked at 10 min intervals for a total of 3 intervals (30 min). ]

Central Contacts and Locations

Locations

Next Level Urgent Care

Recruiting

Houston, Texas, United States, 77057

Contacts

More Information

Sponsor

NasaClip

Last update posted

Nov 22, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NasaClip on 2023-11-22.