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Trial Outcomes & Findings for Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain (NCT NCT04466111)

NCT ID: NCT04466111

Last Updated: 2024-08-19

Results Overview

The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.

Recruitment status

COMPLETED

Target enrollment

58 participants

Primary outcome timeframe

3 months

Results posted on

2024-08-19

Participant Flow

1 subject was withdrawn by physician before starting the trial phase.

This is a single-arm observational study.

Participant milestones

Participant milestones
Measure
Subjects Treated With DTM SCS Programming
Subjects that met inclusion and exclusion criteria are trialed with DTM SCS programming.
Prior to Trial Phase
STARTED
58
Prior to Trial Phase
COMPLETED
57
Prior to Trial Phase
NOT COMPLETED
1
Trial Phase
STARTED
57
Trial Phase
COMPLETED
52
Trial Phase
NOT COMPLETED
5
Permanent Implant
STARTED
52
Permanent Implant
COMPLETED
46
Permanent Implant
NOT COMPLETED
6
3 Months
STARTED
46
3 Months
COMPLETED
43
3 Months
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Subjects Treated With DTM SCS Programming
Subjects that met inclusion and exclusion criteria are trialed with DTM SCS programming.
Prior to Trial Phase
Physician Decision
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Subjects Treated With DTM SCS Programming
n=52 Participants
Subjects that met inclusion and exclusion criteria are trialed with DTM SCS programming.
Age, Continuous
56 years
STANDARD_DEVIATION 21 • n=52 Participants
Sex: Female, Male
Female
37 Participants
n=52 Participants
Sex: Female, Male
Male
15 Participants
n=52 Participants
Region of Enrollment
United States
52 participants
n=52 Participants
Upper Limb Pain
7.25 units on a scale
STANDARD_DEVIATION 1.22 • n=52 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All subjects who receive a permanent SCS system implant. Does not include subjects that failed the trial phase nor subjects that did not receive permanent SCS system.

The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.

Outcome measures

Outcome measures
Measure
Subjects Treated With DTM SCS Programming
n=43 Participants
Subjects that met inclusion and exclusion criteria are trialed with DTM SCS programming.
Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months
100 percentage of individual responder
Interval 91.78 to 100.0

Adverse Events

Subjects Treated With DTM SCS Programming

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Subjects Treated With DTM SCS Programming
n=58 participants at risk
Subjects that met inclusion and exclusion criteria are trialed with DTM SCS programming.
Nervous system disorders
Spinal cord bruising
1.7%
1/58 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure
Subjects Treated With DTM SCS Programming
n=58 participants at risk
Subjects that met inclusion and exclusion criteria are trialed with DTM SCS programming.
Musculoskeletal and connective tissue disorders
Pocket Pain
5.2%
3/58 • Number of events 3 • 1 year

Additional Information

VP of Clinical

SGX Medical

Phone: 818-527-2710

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place