Long-term Surveillance of the MedStream Programmable Infusion System

NCT01712087 | Terminated DMC

• 1 other identifier: NM-PMK-1001
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm Scores over the 36-month follow-up period will also be described.

Conditions

Spasticity

Keywords

spasticity; muscle spasticity; muscle rigidity; motor neuron disease; hyperreflexia

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)

  The primary endpoint is the incidence of MedStream system-related AEs (MedStream pump and catheters) based on Clinical Events Committee determination of relationship, that occur from the start of the MedStream implant procedure (incision) until completion of the 24 month follow-up visit

  24 Months

Secondary Outcomes (9)

• MedStream system-related AEs occurring from 24 to 36 months

  36 Months

• Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.

  24 Months

• Procedure-related AEs

  24 Months

• Drug-related AEs associated with intrathecal Baclofen

  24 Months

• Drug-related AEs associated with other intrathecally-administered medications

  24 Months

Study Arms (1)

MedStream System Implants

All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen.

Device: MedStream Programmable Infusion System

Interventions

MedStream Programmable Infusion System DEVICE

Intrathecal Infusion of Baclofen in the Treatment of Spasticity

Also known as: MedStream, MedStream Pump, MedStream programmable pump, MedStream Intrathecal Infusion System, MedStream Infusion system

MedStream System Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen are potential study candidates and will be screened for study eligibility. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled into this study.

You may qualify if:

• The subject is a viable candidate for "de novo" or continued (pump replacement) therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by an implantable programmable pump.
• The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study in accordance with 21 Code of Federal Regulations (CFR) Part 50.
• The subject is willing to comply with the protocol-specified follow-up visit requirements for a period of 36 months after implant.
• The subject has an anticipated life expectancy of 24 months or greater.
• The subject must be 18 years of age or older at time of MedStream implant procedure.
• The subject is of sufficient body size to accommodate pump placement, in the opinion of the Investigator.
• The subject will receive a de novo or replacement implant of the MedStream 20 mL or 40 mL pump, MedStream approved catheter(s) and MedStream accessories.
• The Investigator intends to use Baclofen in the pump for treatment of severe spasticity
• The subject is capable of self-reporting spasm frequency.

You may not qualify if:

• Concurrent enrollment in an investigational device or drug study that has not completed the required follow-up period.
• Subject has had an infection and/or inflammation at or near the pump and/or catheter implantation site(s) within 30 days preceding enrollment.
• Evidence of a fever or infection within 10 days prior to the surgical implant procedure that, in the opinion of the Investigator might impact a successful pump implant.
• The subject has known hypersensitivity/allergies or contraindication to Baclofen or the materials in the infusion pump or catheter(s).
• The subject has a co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements or, which might impact the scientific integrity of the study.
• The subject has a rapid degenerative neurological disease such as lateral sclerosis, amyotrophic lateral sclerosis (ALS), rapidly progressive Multiple Sclerosis, inherited or rapidly progressive leukodystrophies, Moyamoya disease, cerebral autosomal dominant arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL), thrombophilias, rapidly progressive autoimmune disorders, or any disorder where progression of the underlying spinal cord or a central nervous system (CNS) disease is expected to progress significantly over the next 3 years
• Subject is a prisoner.
• Subject was previously enrolled in this study.
• Subject is pregnant or breastfeeding. (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Sponsors & Collaborators

• Codman & Shurtleff: lead

Study Sites (2)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Muscle Spasticity; Muscle Rigidity; Motor Neuron Disease; Reflex, Abnormal

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodegenerative Diseases; Neuromuscular Diseases

Study Officials

• Jonathan T Megerian, MD

  Codman & Shurtleff

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 23, 2012
• Study Start: October 1, 2012
• Primary Completion: December 17, 2017
• Study Completion: December 17, 2017
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

US (2)