Status:
WITHDRAWN
An Open-Label Trial of PEMF Therapy [Provant Infinity Therapy System] for Home Use in Postoperative Pain
Lead Sponsor:
Regenesis Biomedical, Inc.
Conditions:
Postoperative Pain
Eligibility:
All Genders
22-80 years
Phase:
NA
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.
Detailed Description
This is an 8-week (56 days ± 3 days), multi-center, open label clinical trial conducted on subjects with chronic postoperative pain. Eligible subjects will include those between 22 and 80 years of ag...
Eligibility Criteria
Inclusion
- 1\. 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.
- 3\. Subject's age is greater than or equal to 22 years and less than 80 years of age.
- 4\. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
- 5\. 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.
Exclusion
- 1\. Subject has a history of previous solid organ transplant or severe renal disease (i.e. estimated creatinine clearance \<30 mL/min).
- 2\. Subject has previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, or HIV infection.
- 3\. 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).
- 4\. 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.
- 5\. 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.
- 6\. Subject has received any investigational drug or device within 30 days prior to the Screening Visit.
- 7\. Subject has a history of malignancy within the past 5 years in the treatment area.
- 8\. Subject has severe mental health or psychiatric disorder that would interfere with study performance and/or assessments in the opinion of the Investigator.
- 9\. Subject has a known history of drug or alcohol abuse within one year prior to the Screening Visit.
- 10\. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
- 11\. Subject is currently pregnant or planning to become pregnant prior to Week 8.
- 12\. Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04300907
Start Date
March 1 2020
End Date
March 24 2020
Last Update
April 6 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Physician's Research Group
Mesa, Arizona, United States, 85206
2
Valley Clinical Research
Northridge, California, United States, 91325
3
Lake Internal Medicine Associates
Eustis, Florida, United States, 32726
4
Palm Research Center
Las Vegas, Nevada, United States, 89128