An Open-Label Trial of PEMF Therapy [Provant Infinity Therapy System] for Home Use in Postoperative Pain

NCT04300907 | Withdrawn FDA Device

• 1 other identifier: RBI.2020.002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

A study of the use of the Provant Infinity Therapy System when treatment is administered 30 minutes twice daily for 8-weeks (56 days ± 3 days) at home for postoperative pain.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Device Use Questionnaire

  4 question questionnaire on device usage (total of all responses will be counted at the end of the study); response will require a "Yes" or "No" answer

  Week 8

Secondary Outcomes (2)

• Device Feedback Questionnaire

  Week 8

• Numeric Pain Rating Scale (NPRS)

  Weeks 2, 4, 6 and 8

Study Arms (1)

Provant Infinity Therapy

EXPERIMENTAL

Open-label treatment with Provant Infinity Therapy

Device: Provant Infinity Therapy System

Interventions

Provant Infinity Therapy System DEVICE

Treatment with the Provant Infinity Therapy System, PEMF device

Provant Infinity Therapy

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject is ≥ 60 days postoperative. 2. Subject's average chronic postoperative pain over the preceding week is ≥4 and \<9, based on the 11-point NPRS (0-10) at the Screening Visit.
• \. Subject's age is greater than or equal to 22 years and less than 80 years of age.
• \. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
• \. Female subjects must be postmenopausal, surgically sterile, abstinent, or, if of childbearing potential, practicing (or agrees 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 has a history of previous solid organ transplant or severe renal disease (i.e. estimated creatinine clearance \<30 mL/min).
• \. Subject has previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, or HIV infection.
• \. According to the judgment of the Investigator, subject has clinically significant cardiovascular disease within 6 months prior to screening (unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, arrhythmia, cardiac surgery, stent placement or angioplasty, or congestive heart failure).
• \. Subject has a history of any uncontrolled medical illness that, in the investigator's judgment, places the subject at unacceptable risk for enrollment in a research trial with pulsed electromagnetic field therapy.
• \. Subject requires or anticipates the need for surgery (other than minor outpatient surgical procedures, such as dental or minor cosmetic procedures) or extended travel during the treatment period.
• \. Subject has received any investigational drug or device within 30 days prior to the Screening Visit.
• \. Subject has a history of malignancy within the past 5 years in the treatment area.
• \. Subject has severe mental health or psychiatric disorder that would interfere with study performance and/or assessments in the opinion of the Investigator.
• \. Subject has a known 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 to become pregnant prior to Week 8.
• \. Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits.

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (4)

Physician's Research Group

Mesa, Arizona, 85206, United States

Location

Valley Clinical Research

Northridge, California, 91325, United States

Location

Lake Internal Medicine Associates

Eustis, Florida, 32726, United States

Location

Palm Research Center

Las Vegas, Nevada, 89128, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Model Details: open-label

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 9, 2020
• Study Start: March 1, 2020
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)