Clinical trial · Interventional
Quell Opioid Reduction and Pain Relief in Patients With Cancer
NCT02809846CI-TRIAL-00042875terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit enough participants.
Summary
Brief summary (as posted)
To study effects the Quell device has on opioid consumption and pain relief in patients with cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quell | Device | — | UNRESOLVED |
| Sham Quell | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Quell Device
- description
- 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.
- interventionNames
- Device: Quell
- type
- SHAM_COMPARATOR
- label
- Sham Quell Device
- description
- Identical to Active Comparator, but provides sub-therapeutic electronic stimulation.
- interventionNames
- Device: Sham Quell
Primary outcomes (1)
- measure
- Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or Female greater than or equal to 18 year of age at visit one. 2. Documented diagnosis of metastatic breast, prostate or colorectal cancer with a prognosis of 6 month or greater as determined by the primary oncologist. 3. Visual evidence that subject owns a smart phone and is able to use basic mobile applications such as downloading an app, opening the app, and performing one simple task within the app. 4. Subject speaks and reads English fluently. 5. Subject able to understand and grant informed consent. 6. Live in an area with cellular data connectivity available as provided by the subject. 7. Documented adherence with clinic follow up visits per medical records. 8. Subject using at least one opioid medication on a daily basis. Exclusion Criteria: 1. Subject has a cardiac pacemaker, implanted defibrillator or other implanted electronic device. 2. Inability to complete subjective data as required; e.g. on mobile application and questionnaires. 3. Does not live in an area with suitable cellular data connectivity. 4. Has infrequent scheduled clinic visits.
References
Publications (0)
Data not yet available
No reference posted for this study.