Quell Opioid Reduction and Pain Relief in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT02809846|
Recruitment Status : Terminated (Unable to recruit enough participants.)
First Posted : June 22, 2016
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain Metastatic Breast Cancer Prostate Cancer Colorectal Cancer||Device: Quell Device: Sham Quell||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Quell Opioid Reduction and Pain Relief in Patients With Cancer|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||October 2017|
Active Comparator: Quell Device
Quell is a class II medical device with FDA 510(k) clearance for the symptomatic relief and management of chronic intractable pain, without a prescription. It operates by using an electrical stimulator to activate peripheral sensory nerves and trigger analgesia.
Sham Comparator: Sham Quell Device
Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.
Device: Sham Quell
- Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. [ Time Frame: Weeks: 2,4,6,8,10 ]The primary end point of this study was the difference in the change in daily opioid use between the active device group and the sham device group, assessed at weeks 2, 4, 6, 8, and 10 of the study as recorded by the subject in their analgesia diary. Participants documented which medication was taken, how much, and at what time. Dose and type of opioid pain medication was converted to morphine milliequivalents (MME) using conversion factors published by the Centers for Medicare and Medicaid Services (CMS)and combined as a daily dose for each day in a subject's analgesia journal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809846
|United States, California|
|Scripps Translational Science Institute|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Lase Ajayi, MD||Scripps|