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Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain

NCT04407884 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-05-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the Soovu Labs pain Relief System in a group of users that represent people most likely to purchase and use the units. This study is called an In Home Users Trial (IHUT). The device is called Soovu and was determined by the FDA to be Class II 510(k) except (C190061 November 2019). Relevant endpoints include ease of use, pain relief, quality of life, and long-term effectiveness.

Conditions

  • Pain
  • Pain, Chronic
  • Pain, Back

Interventions

DEVICE

Soovu Labs Inc. Pain Relief System

Longnitual follow-up

Sponsors & Collaborators

  • Soovu Labs Inc.

    lead INDUSTRY

Principal Investigators

  • charles chabal, MD · Soovu Labs

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2020-09-20
Completion
2020-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04407884 on ClinicalTrials.gov