SynchroMed II Post-Approval Study | NCT00773019

Studies
SynchroMed II Post-Approval Study

NCT00773019

Sponsor

MedtronicNeuro

Status

Completed

Last Update Posted

Apr 27, 2023Actual

Enrollment

84Actual

Phase

Not provided

Conditions

Severe Spasticity
Chronic Pain

Interventions

Refills (SynchroMed® II Programmable Drug Infusion Pump)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Jun 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Aug 21, 2008

First Submission Date that Met QC Criteria

Oct 14, 2008

First Posted Date

Oct 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

Apr 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Refills (SynchroMed® II Programmable Drug Infusion Pump)	Device	Refill information at 1, 6, and 12 months post-implant, as well as any additional refills required from implant through end of study. Amount removed from the pump (taken from syringe), Amount placed in the pump (from syringe),Pump predicted amount remaining in the pump.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed		six months

Secondary Outcomes

Measure	Description	Time Frame
Characterize adverse events experienced with the drug infusion system		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication
Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system
Be geographically stable and willing to return to the study center for follow-up visits
Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures
Age is at least 18 years of age at time of enrollment

Exclusion Criteria:

Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin
Have an ongoing infection prior to implant
Have insufficient body mass to accept the pump bulk and weight
Are unable or unwilling to adhere to the study protocol
Have an estimated life expectancy of less than twelve months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects planning to receive a new or replacement drug pump.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009128	Muscle Spasticity
D059350	Chronic Pain

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided