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Nasal Compression Device Study for Epistaxis

Primary Purpose

Epistaxis Nosebleed

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal Compression Device
Routine Care
Sponsored by
NasaClip
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis Nosebleed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION In order to be eligible to participate in this study, an individual must meet all of the following criteria: Presenting with anterior epistaxis determined as someone with venous bleeding that can be controlled with external compression. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, aged at least 18. 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: Known allergic or hypersensitivity reactions to components of NasaClip or oxymetazoline. Less than 18 years of age. Known pregnancy. Unable to provide informed consent. Subjects who are prisoners or who are in police custody. 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. Patients taking MAO inhibitors. Medical instability or need for emergent intervention as determined by on-site medical team.

Sites / Locations

  • Next Level Urgent CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Nasal Compression Device

Arm 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.

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.

Outcomes

Primary Outcome Measures

Primary Outcome - Change over time from full epistaxis to cessation.
Primary outcome is time to bleeding cessation.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2023
Last Updated
June 28, 2023
Sponsor
NasaClip
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1. Study Identification

Unique Protocol Identification Number
NCT05789264
Brief Title
Nasal Compression Device Study for Epistaxis
Official Title
Feasibility Study of a Nasal Compression Device in Comparison to Digital Nasal Compression for Stopping Epistaxis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NasaClip

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis Nosebleed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm 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.
Arm Title
Nasal Compression Device
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Nasal Compression Device
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Routine Care
Intervention Description
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 Information:
Title
Primary Outcome - Change over time from full epistaxis to cessation.
Description
Primary outcome is time to bleeding cessation.
Time Frame
Checked at 10 min intervals for a total of 3 intervals (30 min).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION In order to be eligible to participate in this study, an individual must meet all of the following criteria: Presenting with anterior epistaxis determined as someone with venous bleeding that can be controlled with external compression. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, aged at least 18. 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: Known allergic or hypersensitivity reactions to components of NasaClip or oxymetazoline. Less than 18 years of age. Known pregnancy. Unable to provide informed consent. Subjects who are prisoners or who are in police custody. 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. Patients taking MAO inhibitors. Medical instability or need for emergent intervention as determined by on-site medical team.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wilner Jeudy, Dr.
Phone
281-612-3600
Email
wjeudy@nextlevelurgentcare.com
First Name & Middle Initial & Last Name or Official Title & Degree
Micko Sandford
Phone
281-612-3600
Email
msandford@nextlevelurgentcare.com
Facility Information:
Facility Name
Next Level Urgent Care
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micko Sandford
Phone
832-460-3311
Email
research@nextlevelurgentcare.com
First Name & Middle Initial & Last Name & Degree
Laura Sanata
Phone
832-460-3311
Email
lsantana@nextlevelurgentcare.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26351457
Citation
Traboulsi H, Alam E, Hadi U. Changing Trends in the Management of Epistaxis. Int J Otolaryngol. 2015;2015:263987. doi: 10.1155/2015/263987. Epub 2015 Aug 16.
Results Reference
background
PubMed Identifier
27542804
Citation
Bequignon E, Teissier N, Gauthier A, Brugel L, De Kermadec H, Coste A, Pruliere-Escabasse V. Emergency Department care of childhood epistaxis. Emerg Med J. 2017 Aug;34(8):543-548. doi: 10.1136/emermed-2015-205528. Epub 2016 Aug 19.
Results Reference
background
PubMed Identifier
2370452
Citation
Padgham N. Epistaxis: anatomical and clinical correlates. J Laryngol Otol. 1990 Apr;104(4):308-11. doi: 10.1017/s0022215100112563.
Results Reference
background
PubMed Identifier
2676467
Citation
Guarisco JL, Graham HD 3rd. Epistaxis in children: causes, diagnosis, and treatment. Ear Nose Throat J. 1989 Jul;68(7):522, 528-30, 532 passim.
Results Reference
background
PubMed Identifier
18435996
Citation
Gifford TO, Orlandi RR. Epistaxis. Otolaryngol Clin North Am. 2008 Jun;41(3):525-36, viii. doi: 10.1016/j.otc.2008.01.003.
Results Reference
background
PubMed Identifier
19228621
Citation
Schlosser RJ. Clinical practice. Epistaxis. N Engl J Med. 2009 Feb 19;360(8):784-9. doi: 10.1056/NEJMcp0807078. No abstract available.
Results Reference
background
PubMed Identifier
3950497
Citation
Bende M, Loth S. Vascular effects of topical oxymetazoline on human nasal mucosa. J Laryngol Otol. 1986 Mar;100(3):285-8. doi: 10.1017/s0022215100099151.
Results Reference
background
PubMed Identifier
15686301
Citation
Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. 2005 Jan 15;71(2):305-11.
Results Reference
background
PubMed Identifier
31910111
Citation
Tunkel DE, Anne S, Payne SC, Ishman SL, Rosenfeld RM, Abramson PJ, Alikhaani JD, Benoit MM, Bercovitz RS, Brown MD, Chernobilsky B, Feldstein DA, Hackell JM, Holbrook EH, Holdsworth SM, Lin KW, Lind MM, Poetker DM, Riley CA, Schneider JS, Seidman MD, Vadlamudi V, Valdez TA, Nnacheta LC, Monjur TM. Clinical Practice Guideline: Nosebleed (Epistaxis). Otolaryngol Head Neck Surg. 2020 Jan;162(1_suppl):S1-S38. doi: 10.1177/0194599819890327.
Results Reference
background
PubMed Identifier
10487000
Citation
Doo G, Johnson DS. Oxymetazoline in the treatment of posterior epistaxis. Hawaii Med J. 1999 Aug;58(8):210-2.
Results Reference
background
Links:
URL
https://www.uptodate.com/contents/approach-to-the-adult-with-epistaxis
Description
Approach to the adult with epistaxis - UpToDate
URL
https://emedicine.medscape.com/article/863220-overview#a6
Description
Epistaxis: Practice Essentials, Anatomy, Pathophysiology

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Nasal Compression Device Study for Epistaxis

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