Ultrasonography, PrenatalNCT04399408
Instinct™ Ultrasound Device Safety, Efficacy and Usability
A study testing Obstetrics Ultrasound (non invasive) in people with Ultrasonography, Prenatal, run by PulseNmore at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Prenatal
- What is being tested?
- Obstetrics Ultrasound (non invasive)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 6 May 2019to 25 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18.
- Pregnancy week - 14-40.
- Fetus - single, no known genetic or anatomic defects.
- Able to understand and give informed consent.
Who cannot join
- Multiple pregnancy.
- Known genetic or anatomic defect to the fetus.
- Inability to understand how to operate the device or give informed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability
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.
Read the 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
- Ultrasonography, Prenatal
- Being tested
- Obstetrics Ultrasound (non invasive)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetrics Ultrasound (non invasive)Device
Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Device users Receives: Device: Obstetrics Ultrasound (non invasive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Device related SAE's
The device will be deemed safe if all SAE will be classified as not device related
Measured: Through study completion until all subject gave birth, an average of 1 year
Secondary outcomes (3)
User experience level
User experience will be defined positive if the mean value of all answers to user satisfaction related questions in the CRF is better or equal 3.5 out of 5. Questions will be graded by a visual analog scale with scores of 1 to 5 (1=very poor, 5=very high)
Measured: Through study completion, an average of 1 year
Usability rating
Usability will be defined positive if the mean value of all answers to usability related questions in the CRF is better or equal 3.5 out of 5. Questions will be graded by a visual analog scale with scores of 1 to 5 (1=very poor, 5=very high)
Measured: Through study completion, an average of 1 year
Device Sensitivity level
Medical data recorded by the device will be defined useful if:
At least 70% of 3 out of 5 tested parameters (Fetal Heartbeat, Movements, Tone, Breathing and Amniotic fluids) were classified by professional evaluator as "could be estimated".
In more than 90% of scans, professional evaluator will be able to define Fetal Viability (identification of at least one of the following parameters: Fetal Heartbeat, Movements, Tone and Breathing)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start6 May 2019
- Primary completion20 May 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonography, PrenatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseNmore
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eran Hadar, M.D., Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399408
- Sponsor's protocol ID
- 0004-19-RMC
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability
- ClinicalTrials.gov ID
- NCT04399408
- Acronym / sponsor ID
- 0004-19-RMC
- Conditions
- Ultrasonography, Prenatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PulseNmoreIndustry (pharma, biotech, devices)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Obstetrics Ultrasound (non invasive)Device users |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18.
- Pregnancy week - 14-40.
- Fetus - single, no known genetic or anatomic defects.
- Able to understand and give informed consent.
Key exclusion criteria (3 listed)
- Multiple pregnancy.
- Known genetic or anatomic defect to the fetus.
- Inability to understand how to operate the device or give informed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetrics Ultrasound (non invasive)Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps. | Device | Study group |
Primary outcome
Safety - Device related SAE's
Time frame: Through study completion until all subject gave birth, an average of 1 year
The device will be deemed safe if all SAE will be classified as not device related
3 secondary outcomes
User experience level
Time frame: Through study completion, an average of 1 year
Usability rating
Time frame: Through study completion, an average of 1 year
Device Sensitivity level
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Continuous Wireless Ultrasound to Monitor Fetal Health
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Transabdominal Versus Transvaginal Ultrasound at 9-14 Weeks in High-Risk Pregnancies
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Wearable Ultrasound Patch in Parturients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Hadar, M.D. principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstetrics Ultrasound (non invasive) in people with Ultrasonography, Prenatal, run by PulseNmore at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Device related SAE's (time frame: Through study completion until all subject gave birth, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.