Chronic PainNCT02492880

CoverEdge Algorithm Programming Study

A study testing Precision Spectra™ SCS system programming features in people with Chronic Pain, run by Boston Scientific Corporation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Precision Spectra™ SCS system programming features
Type of treatment: Medical device
How many people: 15 participants
Where: 2 sitesUnited States
Study dates: 20 Jul 2015to 21 Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU).
Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
Subject is 18 years of age or older when written informed consent is obtained.

Who cannot join

Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU.
Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Albany Medical Center
Albany, New York, 12208
Barolat Neuroscience
Denver, Colorado, 80218

Other trials in United States

About this study

Official title: Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads

Conditions: Chronic Pain
Being tested: Precision Spectra™ SCS system programming features
Keywords: stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Medical subject headings: Chronic Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Precision Spectra™ SCS system programming featuresDevice
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
Change in paresthesia distribution based on programming parameters
Measured: minimum 25 days post IPG implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 201521 Feb 2017

First posted9 Jul 2015 (estimated)
Study start20 Jul 2015
Primary completion21 Feb 2017
Study completion21 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02492880
Sponsor's protocol ID: 91051317
Status last verified: Nov 2022
First submitted: 23 Jun 2015
Last updated: 4 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads
ClinicalTrials.gov ID: NCT02492880
Acronym / sponsor ID: 91051317
Conditions: Chronic Pain
Keywords: stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 20 Jul 2015 (actual)
Primary completion: 21 Feb 2017 (actual)
Study completion: 21 Feb 2017 (actual)
First posted: 9 Jul 2015 (estimated)
Results: Posted 7 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU).
Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
Subject is 18 years of age or older when written informed consent is obtained.

Key exclusion criteria (2 listed)

Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU.
Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Precision Spectra™ SCS system programming featuresPrecision Spectra™ SCS system programming features using the CoverEdge surgical lead.	Device	–

Primary outcome

Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
Time frame: minimum 25 days post IPG implant
Change in paresthesia distribution based on programming parameters

Results and safety

Results posted to the registry on 7 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Precision Spectra™ SCS System Programming Features	15	13

Primary outcome: Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire

Time frame: minimum 25 days post IPG implant. Count of participants. Unit: Participants

Measure	Precision Spectra™ SCS System Programming Features n = 13
Yes	13
No	0

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Precision Spectra™ SCS System Programming Features	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roshini Jain study director

Boston Scientific Neuromodulation Corporation

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Precision Spectra™ SCS system programming features in people with Chronic Pain, run by Boston Scientific Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire (time frame: minimum 25 days post IPG implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02492880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022; AzTrials last refreshed its copy on 29 Oct 2026.