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Compression Device
Nasal Compression Device for Nosebleeds
N/A
Recruiting
Research Sponsored by NasaClip
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presenting with anterior epistaxis determined as someone with venous bleeding that can be controlled with external compression.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up checked at 10 min intervals for a total of 3 intervals (30 min).
Awards & highlights
Study Summary
This trial will compare a nasal compression device to manual compression to stop nosebleeds. Participants will evaluate their experience to see which works best.
Who is the study for?
This trial is for adults over 18 in good health who have anterior nosebleeds that can be stopped with pressure. They must be willing to follow the study rules and stay for the whole study. It's not for those allergic to NasaClip or oxymetazoline, pregnant, unable to consent, prisoners, or with uncontrolled high blood pressure, heart disease, thyroid issues, diabetes, prostate problems or on MAO inhibitors.Check my eligibility
What is being tested?
The study compares a nasal compression device against standard manual compression to stop anterior nosebleeds. Participants will either use the new device or receive routine care and then answer questions about their satisfaction and comfort during treatment.See study design
What are the potential side effects?
While specific side effects are not listed for this trial of a nasal compression device versus manual compression; discomfort at the site of application may occur. Any additional side effects would likely relate to individual sensitivity to the materials used in the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have nosebleeds from the front of my nose that stop when pressure is applied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ checked at 10 min intervals for a total of 3 intervals (30 min).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~checked at 10 min intervals for a total of 3 intervals (30 min).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
- Change over time from full epistaxis to cessation.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nasal Compression DeviceExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
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.
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Who is running the clinical trial?
Emergency Medical Innovations, LLCUNKNOWN
NasaClipLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medical team has identified that I have poorly controlled high blood pressure, heart disease, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate.I am currently taking MAO inhibitors.I do not require immediate medical intervention for any condition.I am 18 years old or older.I am under 18 years old.I am able to understand and agree to the study's procedures and risks.I have nosebleeds from the front of my nose that stop when pressure is applied.
Research Study Groups:
This trial has the following groups:- Group 1: Nasal Compression Device
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor actively seeking to expand its participants?
"According to clinicaltrials.gov, this medical experimentation is currently recruiting patients and has been doing so since March 1st 2023 (most recently edited on the 15th of that same month)."
Answered by AI
What is the current selection quota for this trial?
"Affirmative. According to clinicaltrials.gov, this trial is currently enrolling patients that meet their requirements. Initially posted on March 1st 2023 with the most recent update occurring on March 15th 2023, 40 individuals are being sought by a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Next Level Urgent Care
What portion of applicants met pre-screening criteria?
Met criteria
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