Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Novel restraint · 1 trial · 1 indication
Safety will be measured by the number (i.e. \< 1 in 5 participants had a treatment emergent safety event per their on study time) across all of the following measures listed below. Incidence does not have to be per person-year; in this case it is incidence of safety adverse event during the study period.
Grade 2b or higher skin laceration (per Skin Tear Audit Research \[STAR\] Skin Tear Classification System) in patient or clinician from any sharp edges of device. The STAR grading system ranges from grade 1a at best to 3 at worst. Each laceration is given an individual score based on appearance.
Development of pressure ulcer from device of Stage 3 or greater per 2016 National Pressure Ulcer Advisory Panel Pressure Injury Stages. This staging system provides an individual score to each pressure ulcer based on appearance from stage 1 (best) to stage 4 (worst)
Self-removal of novel restraint
Any damage to hospital bed from restraint device rendering it non-functional
Any damage to ICU equipment (e.g. ventilator) rendering it non-functional
| Arm | Type | Description |
|---|---|---|
| Novel restraint first, then traditional restraint | EXPERIMENTAL | Participants will be randomized to wear the novel arm restraint bilaterally for 4 hours on study day #1, followed by traditional soft bilateral wrist restraints for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. |
| Traditional restraint first, then novel restraint | EXPERIMENTAL | Participants will be randomized to wear traditional soft bilateral wrist restraints for 4 hours on study day #1, followed by the novel arm restraint bilaterally for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. |
| Name | Type | Description |
|---|---|---|
| Novel restraint | DEVICE | Use of a novel arm restraint |
Inclusion Criteria: 1. \>65 years old 2. Physician order for use of bilateral wrist restraints 3. Requiring mechanical ventilation with actual or expected total duration of \>48 hours 4. Expected ICU stay \>3 days after enrollment (to permit adequate exposure to proposed intervention) 5. Not deeply...
Novel restraint is an investigational device being studied for use in patients with Acute Respiratory Failure. It is being evaluated in a clinical trial conducted in the intensive care unit setting, with the aim of assessing its effects in this patient population.
Novel restraint is being developed by Design Therapeutics, Inc., a company listed on the stock exchange under the ticker symbol DSGN. The company is conducting clinical research to evaluate this investigational device.
Novel restraint is currently in Phase 1 of clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the product remains under investigation.
Novel restraint has been studied in one clinical trial with the identifier NCT03621475, titled 'Novel Arm Restraint in the Intensive Care Unit.' This Phase 1 trial was completed in the United States and enrolled 8 participants with Acute Respiratory Failure.
Novel restraint is not known to have any alternative names. It is a distinct investigational product being developed by Design Therapeutics, Inc. for the management of Acute Respiratory Failure in the intensive care unit setting.