NCT07813091

Brief Summary

This study aims to test the oxygen saturation component of the newly developed NeWTS monitoring system and compare readings from NeWTS to a traditional wired clinical monitor. It is important the investigators do this study in healthy adults as part of the development of this system, to make sure the oxygen saturation readings are accurate and before NeWTS is used in Neonatal Intensive Care (NICU).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
8mo left

Started Jan 2027

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2027

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2027

27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

September 10, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 27, 2026

Last Update Submit

September 8, 2026

Conditions

Testing AccuracyDevice Performance

Keywords

Neonatal Wireless Transmission System (NeWTS)Controlled oxygen desaturation

Outcome Measures

Primary Outcomes (1)

  • Validation of SpO2 performance

    Validation of the SpO2 performance of the NeWTS in comparison to "gold standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser.

    From enrolment to end of study 3-4 hours

Study Arms (1)

Controlled Oxygen Desaturation of Healthy Adult Volunteers

OTHER
Device: Neonatal Wireless Transmission System

Interventions

Neonatal Wireless Transmission SystemDEVICE

The primary objective for this clinical investigation is to validate the SpO2 performance of the NeWTS in comparison to "gold-standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser.

Controlled Oxygen Desaturation of Healthy Adult Volunteers

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsminimum 33% female biological sex and 33% male biological sex as per ISO 80601-2-61:2026
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be aged 18-55 years
  • Willing and have capacity to provide written informed consent
  • Healthy adult volunteers classified as ASA 1
  • Non-smoker (this does not exclude vaping)
  • Willing and able to comply with study procedures and duration

You may not qualify if:

  • History of Bleomycin treatment at any time
  • Smokers or individuals exposed to high levels of carbon monoxide
  • Compromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the study
  • Morbidly obese (defined as BMI \>39.5) or significantly underweight (BMI \<18)
  • Pregnancy
  • Participants who can conceive a pregnancy or carry a child (including women, trans men and non-binary people) will be required to demonstrate a negative pregnancy test
  • Unwillingness or inability to remove coloured nail polish or nail attachments from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached
  • Known health conditions or medications disclosed on Health Assessment Form which mean that participant is not healthy
  • Allergy to lidocaine
  • Known allergy to adhesives used in medical dressings or tapes or materials used to adhere NeWTS components.
  • Enrolment in any other clinical investigation/trial that is deemed would compromise the validity of the data or safety of the patient (at the discretion of the local PI)
  • Sunburn/spray tan or other pigments on hands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Facility

Birmingham, England, B15 2GW, United Kingdom

Location

Study Officials

  • Kathryn Beardsall, MD

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Beardsall, MD

CONTACT

+447565 964631kb274@cam.ac.uk

Catherine Guy, BSc(Hons)

CONTACT

cc570@cam.ac.uk

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 10, 2026

Study Start (Estimated)

January 11, 2027

Primary Completion (Estimated)

August 4, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

September 10, 2026

Record last verified: 2026-08

Locations

GB(1)