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NCT03443388 · ClinicalTrials.gov registry record · NA
Novel Helmet Design in Patients With Seizures
A NA study of Drug Resistant Epilepsy and Generalized Tonic Clonic Seizure, sponsored by Michael A. Gelfand, MD, PhD.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT03443388: Completed NA study of Drug Resistant Epilepsy and Generalized Tonic Clonic Seizure, sponsored by Michael A. Gelfand, MD, PhD.
NCT03443388 is a NA study of Drug Resistant Epilepsy and Generalized Tonic Clonic Seizure that has completed, run by Michael A. Gelfand, MD, PhD. The registered enrollment target is 9 participants, below the 35-participant average among 6 other Drug Resistant Epilepsy trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03443388, a NA study of Drug Resistant Epilepsy and Generalized Tonic Clonic Seizure, has completed, sponsored by Michael A. Gelfand, MD, PhD.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a two-part study that aims to determine the reliability and safety of the use of the Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qualitative patient reporting.
Primary Outcome
3 out of 4 successful deployments was set as a criteria to allow advancement to part 2.
Conditions Studied
Interventions
- DEVICE Hövding inflatable helmet
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-08-14 |
| Est. Completion | 2020-03-20 |
| Phase | NA |
What the finished NCT03443388 record still lists
NCT03443388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 35-participant average among 6 other Drug Resistant Epilepsy trials with a reported enrollment target (74% lower).
The record links to 5 conditions, with Drug Resistant Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Hövding inflatable helmet is the first listed.
NCT03443388 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03443388 about?
NCT03443388 is a clinical study titled "Novel Helmet Design in Patients With Seizures". This is a two-part study that aims to determine the reliability and safety of the use of the Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qualitative patient reporting.
What is the current status of trial NCT03443388?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2017-08-14. Estimated completion is 2020-03-20.
What conditions does trial NCT03443388 study?
This clinical trial studies the following conditions: Drug Resistant Epilepsy, Generalized Tonic Clonic Seizure, Drop Seizures, Complex Partial Seizure, Fall Due to Seizure.
What interventions are being tested in trial NCT03443388?
The interventions under investigation include: Hövding inflatable helmet (DEVICE).
Who is sponsoring clinical trial NCT03443388?
This trial is sponsored by Michael A. Gelfand, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03443388 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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