Trial Outcomes & Findings for Quell Opioid Reduction and Pain Relief in Patients With Cancer (NCT NCT02809846)

Last Updated: 2020-01-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Weeks: 2,4,6,8,10

Results posted on

2020-01-21

Participant Flow

Study was conducted at the Scripps Mercy Oncology Clinic in San Diego California. Enrollment began on Wednesday 7/5/216. The last participant completed on 7/27/17 . The trial was terminated before reaching the projected sample size because of unanticipated difficulties in the recruitment and retention of individuals with targeted conditions.

Participant milestones

Participant milestones
Measure	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. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell	Sham Quell Device Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz Sham Quell
Overall Study STARTED	17	16
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quell Opioid Reduction and Pain Relief in Patients With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quell Device n=17 Participants 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. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell	Sham Quell Device n=16 Participants Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz Sham Quell	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks: 2,4,6,8,10

Outcome measures

Outcome measures
Measure	Quell Device n=8 Participants 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. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell	Sham Quell Device n=9 Participants Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz Sham Quell
Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. Week 0 (Baseline)	51.1 MME Standard Deviation 40.8	41.3 MME Standard Deviation 46.7
Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary. Week 10	27.0 MME Standard Deviation 33.7	38.5 MME Standard Deviation 15.6

Adverse Events

Quell Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Sham Quell Device

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Quell Device n=17 participants at risk 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. For the active device, a therapy session consisted of one hour of continuous stimulation with high frequency electric nerve stimulation varying between 60 and 100 Hz. Quell	Sham Quell Device n=16 participants at risk Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.For the sham device, a therapy session consisted of three 2-minute periods of stimulation at 0, 28 and 58 minutes with a frequency that also varied between 60 and 100 Hz Sham Quell
Skin and subcutaneous tissue disorders Device sensitivity	0.00% 0/17 • Adverse events were tracked from the moment of enrollment till the subject completed the study or was discontinued from the study.	25.0% 4/16 • Number of events 4 • Adverse events were tracked from the moment of enrollment till the subject completed the study or was discontinued from the study.

Additional Information

Lase Ajayi

Scripps TSRI

Phone: 785.218.1643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place