NCT05789264

Nasal Compression Device Study for Epistaxis

Feasibility Study of a Nasal Compression Device in Comparison to Digital Nasal Compression for Stopping Epistaxis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NasaClip · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Epistaxis Nosebleed

Interventions

Type	Name	Description
DEVICE	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-09-26
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2023-03-29
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study