Safety of Pulsing Heating Device Use on the Skin

NCT ID: NCT05427877

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-06-30

Brief Summary

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We hope to assess the safety of a recurrent heating device for pain relief.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Heating Device Application

Heating devices will be applied to the trunk and extremities of the body.

Group Type EXPERIMENTAL

Heating device (Heatwave Technology)

Intervention Type DEVICE

Heating devices will be applied to the trunk and extremities of the body during the first study visit. During each heating cycle, the temperature will increase quickly from room temperature to a high of 45C and then cycle back down. Each heating cycle is 30 minutes with a 3 minute cool down period where no heat is applied. The maximum temperature used in this study is 45 degrees C (113 degrees F). There will be a total of 3 heating cycles at the visit.

Interventions

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Heating device (Heatwave Technology)

Heating devices will be applied to the trunk and extremities of the body during the first study visit. During each heating cycle, the temperature will increase quickly from room temperature to a high of 45C and then cycle back down. Each heating cycle is 30 minutes with a 3 minute cool down period where no heat is applied. The maximum temperature used in this study is 45 degrees C (113 degrees F). There will be a total of 3 heating cycles at the visit.

Intervention Type DEVICE

Other Intervention Names

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Soovu heating devices (Heatwave Technology)

Eligibility Criteria

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Inclusion Criteria

* Individuals in good general health.
* No known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Subjects 18 year of age and older.

Exclusion Criteria

* Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator.
* Individuals with peripheral neuropathy or a neuropathic condition that would alter their ability to sense pain.
* Individuals with clinically significant unstable medical disorders that would disqualify the participant at the discretion of the investigator.
* Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.
* Women who are pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soovu Labs Inc.

INDUSTRY

Sponsor Role collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Jessica Maloh, ND

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Countries

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United States

Central Contacts

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Jessica Maloh, ND

Role: CONTACT

9167502463

Facility Contacts

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Jessica Maloh, ND

Role: primary

916-750-2463

Other Identifiers

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Soovu_01

Identifier Type: -

Identifier Source: org_study_id

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