CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 target
Drug / intervention
Suture +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01126983
NCT01126983N/ACompleted
CompareCT.gov

Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor Securing Methods: A Randomized Single Blind Clinical Trial for Better Outcomes.

Spine Care, Oklahoma·interventional·Posted May 20, 2010·Updated Jul 9, 2010

In Brief

A clinical study evaluating Suture and Lead Anchor for Spinal Cord Stimulation. Completed, enrolled 50 participants across 1 site.

Detailed Summary

To assess lead migration rates using different methods of securing leads during Spinal Cord Stimulation trial period. Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent implantation. Trial lasts less than a week, which gives the patient an opportunity to assess the effectiveness of the treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Stimulation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 20, 2010
Enrollment StartMay 1, 2010
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.1 years ago

Interventions

Suturedevice

Suture (2.0 Mono-filament nylon suture) will be used to secure the leads to the skin. Benzoin and Steri-strips will also be used.

Lead Anchordevice

Suture (2.0 Mono-filament Nylon suture) will be applied over the lead anchor(Lead Anchor St.Jude Medical Co, model-long, No# 1106) to the skin. Benzion and Steri-strips will also be used.