Trial · NCT01712087
Long-term Surveillance of the MedStream Programmable Infusion System
NCT01712087, Terminated, Codman & Shurtleff
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Surveillance of the MedStream Programmable Infusion System. Trials, record NCT01712087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712087
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Surveillance of the MedStream Programmable Infusion System
- NCT number
- NCT01712087
- Status
- Terminated
- Enrollment
- 2 participants, actual
- Lead sponsor
- Codman & Shurtleff
- Conditions
- Spasticity
- Interventions
- MedStream Programmable Infusion System
- First posted
- 2012-10-23
- Last updated
- 2019-01-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoint is the incidence of MedStream system-related Adverse Events (AE) | 24 Months | 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 |
| 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. | 24 Months | 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 |
| Secondary | Procedure-related AEs | 24 Months | 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. |
| 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 | 24 Months | 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. |
| 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 | 24 Month | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01712087
GET https://conductscience.org/api/trials/v1/NCT01712087/registered