NCT02881112

Brief Summary

The study is an open-label, non-controlled study of the safety and effectiveness of investigator determined Provant therapy in subjects with pain and/or edema from various pain etiologies. Information collected in the study will be entered into a registry database.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable pain

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 25, 2019

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

June 30, 2016

Results QC Date

September 23, 2019

Last Update Submit

April 3, 2020

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Assessment

    Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary.

    Pain scores collected daily, up to 20 weeks.

Study Arms (1)

Active Treatment Arm

EXPERIMENTAL

Treatment with Provant Therapy System

Device: Provant Therapy System

Interventions

Provant Therapy SystemDEVICE

Treatment with the Provant Therapy System

Active Treatment Arm

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject age is greater than or equal to 22 years.
  • Subject has pain (chronic or acute) and/or edema that the prescriber deems treatment with Provant is warranted.
  • Subject is willing and able to give written informed consent.
  • Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).

You may not qualify if:

  • Subject requires or anticipates the need for surgery of any type during the duration of treatment.
  • Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.
  • Subject has used systemic corticosteroids within 2 months of the Screening Visit.
  • Subject has a history of a solid tumor that is not in complete remission for greater than 2 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area.
  • Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).
  • Subject has a serious psychosocial co-morbidity.
  • Subject has a history of drug or alcohol abuse within one year prior to the Screening Visit.
  • Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
  • Subject is currently pregnant or planning on becoming pregnant during the treatment period.
  • Subject has been previously treated with the Provant Therapy System.
  • Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

AOC-Research, LLC

Birmingham, Alabama, 35209, United States

Location

Coolbody Contours

Scottsdale, Arizona, 85251, United States

Location

Scottsdale Center for Women's Health

Scottsdale, Arizona, 85258, United States

Location

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Location

Injury Care Research, LLC

Boise, Idaho, 83713, United States

Location

Exodus Pain Clinic

Meridian, Idaho, 83642, United States

Location

Biogenesis Group, LLC

Ypsilanti, Michigan, 48197, United States

Location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Operations Manager
Organization
Regenesis Biomedical
heather.vanderploeg@regenesisbio.com
602-428-7041

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

August 26, 2016

Study Start

March 1, 2016

Primary Completion

December 14, 2017

Study Completion

December 14, 2017

Last Updated

April 6, 2020

Results First Posted

November 25, 2019

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(8)