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A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02335489
Recruitment Status : Terminated (A significant local issue has to led to the suspension of recruitment, this study will be terminated in the coming months)
First Posted : January 9, 2015
Results First Posted : August 2, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Chronic Neuropathic Pain
Intervention Device: Implantation with the commercially available Axium neurostimulator
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Enrolled Subjects
Hide Arm/Group Description All subjects enrolled into the study with intent to treat with the Axium Neurostimulator for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Period Title: Overall Study
Started 10
Received Trial System 9
Receiving Permanent System 8
Completed 0
Not Completed 10
Reason Not Completed
Sponsor terminated study             4
Lost to Follow-up             1
Withdrawal by Subject             2
Physician Decision             2
Lack of Efficacy             1
Arm/Group Title All Enrolled Subjects
Hide Arm/Group Description All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
54
(25 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
7
  70.0%
Male
3
  30.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  10.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Belgium Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
Hide Description The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).
Time Frame Baseline, 3, 6 and12-Months
Hide Outcome Measure Data
Hide Analysis Population Description
Differences in participants over time is due to early withdrawals and missing data
Arm/Group Title All Enrolled Subjects
Hide Arm/Group Description:
All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 8 participants
8.0  (1.5)
3-Months Number Analyzed 4 participants
4.7  (3.2)
6-Months Number Analyzed 4 participants
6.4  (2.3)
12-Months Number Analyzed 2 participants
5.4  (0.3)
Time Frame All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Enrolled Subjects
Hide Arm/Group Description All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
All-Cause Mortality
All Enrolled Subjects
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Enrolled Subjects
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Musculoskeletal and connective tissue disorders   
Central disc hernia at L5-S1 and discreet bulging at L4-L5  1/10 (10.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Enrolled Subjects
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Injury, poisoning and procedural complications   
Headache and nausea [1]  1/10 (10.00%)  1
[1]
These Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Roni Diaz
Organization: St. Jude Medical
Phone: +1 972 309 8601
EMail: rdiaz@sjm.com
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02335489     History of Changes
Other Study ID Numbers: 14-SMI-2013
First Submitted: January 7, 2015
First Posted: January 9, 2015
Results First Submitted: April 24, 2017
Results First Posted: August 2, 2017
Last Update Posted: February 4, 2019