Trials / Completed
CompletedNCT04399408
Instinct™ Ultrasound Device Safety, Efficacy and Usability
Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- PulseNmore · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone in remote pregnancy assessment. Study aims to evaluate its safety, efficacy and usability.
Detailed description
Study includes women carrying a singleton fetus at 14 to 40 gestational weeks. Women with multiple gestations, non-viable fetus at recruitment and those with a major fetal anatomical malformation or genetic syndrome are excluded. Each participant receives the device for a self-use period of 7-14 days, instructed to preform 1-3 scans a day. Each participant completes a self-assessment questionnaire which aims to evaluate satisfactory and usability (user experience and satisfaction). Each scan will be evaluated for the possibility to properly view fetal heart activity, amniotic fluid volume, fetal tone, fetal body and breathing movements.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Obstetrics Ultrasound (non invasive) | Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps. |
Timeline
- Start date
- 2019-05-06
- Primary completion
- 2020-05-20
- Completion
- 2020-07-25
- First posted
- 2020-05-22
- Last updated
- 2023-04-26
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04399408. Inclusion in this directory is not an endorsement.