Long-term Surveillance of the MedStream Programmable Infusion System

Spasticity Clinical Trial

Official title:

Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01712087
• Other study ID #: NM-PMK-1001
• Status: Terminated
• Start date: October 1, 2012
• Est. completion date: December 17, 2017

Study information

• Verified date: January 2019
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 17, 2017
• Est. primary completion date: December 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Intervention

Device:
• MedStream Programmable Infusion System
Intrathecal Infusion of Baclofen in the Treatment of Spasticity

Locations

Country	Name	City	State
United States	Methodist Hospital Research Institute	Houston	Texas
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MedStream system-related AEs occurring from 24 to 36 months		36 Months
Secondary	Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.	Device-related AEs occurring in subjects with both MedStream and non-MedStream devices used or implanted during the course of the study. Device refers to the pump and intrathecal catheters	24 Months
Secondary	Procedure-related AEs	Procedure-related AEs including, but not limited to the following study procedures: MedStream system implant, pump refill and bolus, and reprogramming. If non-MedStream devices or components are utilized in these procedures, this will be described.	24 Months
Secondary	Drug-related AEs associated with intrathecal Baclofen		24 Months
Secondary	Drug-related AEs associated with other intrathecally-administered medications		24 Months
Secondary	Disease-related AEs associated with pre-existing conditions	Disease-related AEs associated with pre-existing conditions that demonstrate a significant worsening of the disease or an increase in the frequency of episodes since baseline, as determined by the investigator.	24 Months
Secondary	Serious Adverse Events (SAEs)		36 Months
Secondary	Unanticipated Adverse Device Effects (UADEs)		24 Months
Secondary	The secondary effectiveness endpoints will be long-term effectiveness of MedStream System	Long-term effectiveness as demonstrated by scores on the Ashworth Scale (lower extremity) and the frequency and severity components of the Penn Spasm Frequency Scale (PSFS) measured pre-implant, post-implant and at each of the protocol-specified study visits.	24 Month