Number of Participants With Non-infection Within One Year
Primary
· 1 year
Non-infection rate of a subject within one year
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm, Single Arm Study | 5 |
Last reviewed · How we verify
NCT04285489
A Study on the Safety of Hakim Programmable Shunt System
Completed
Results posted
Last updated 5 November 2021
What this trial tests
trial testing Hakim Shunt Programmable System in Hydrocephalus in 130 participants. Completed in 28 July 2020.
Timeline
2 May 2020
Primary endpoint
28 July 2020
28 July 2020
28 July 2020
Quick facts
| Lead sponsor | Integra LifeSciences Corporation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 130 |
| Start date | 2 May 2020 |
| Primary completion | 28 July 2020 |
| Estimated completion | 28 July 2020 |
| Sites | 5 locations across China |
Drugs / interventions tested
- Hakim Shunt Programmable System
Conditions studied
- Hydrocephalus — all drugs for Hydrocephalus →
Sponsor
Integra LifeSciences Corporation — full company profile →
Who can join
Adults 2 to 80, any sex, with Hydrocephalus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: within 1 year after investigated device implanted. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
HAKIM Programmable Shunt System Arm
Serious: 31/130 (24%)
Deaths: 4/130
Serious adverse events (8 terms)
| Reaction | System | HAKIM Programmable Shunt S… |
|---|---|---|
| Neurological disorders | Nervous system disorders | — |
| Product problems | Product Issues | — |
| Intracranial infection | Respiratory, thoracic and mediastinal disorders | — |
| Injuries | Injury, poisoning and procedural complications | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | — |
| Craniosynostosis | Congenital, familial and genetic disorders | — |
Other adverse events (3 terms — click to expand)
| Reaction | System | HAKIM Programmable Shunt S… |
|---|---|---|
| Product problems | Product Issues | — |
| Pneumonia | Infections and infestations | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Neurological disorders, Product problems, Intracranial infection, Injuries, Pneumonia, tumor, Upper respiratory tract infection, Craniosynostosis.
Data from ClinicalTrials.gov NCT04285489 adverse events section.
Sponsor's own description
This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04285489
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Integra LifeSciences Corporation trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04285489 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Integra LifeSciences Corporation
- Last refreshed: 5 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04285489.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing