TCOM Ring Evaluation | NCT05640973

Studies
TCOM Ring Evaluation

NCT05640973

Sponsor

Milton S. Hershey Medical Center

Status

Withdrawn

Last Update Posted

Sep 21, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Carbon Dioxide Partial Pressure Determination, Transcutaneous

Interventions

Evaluation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Device was FDA approved before feasibility study could be performed

Expanded Access Info

Start Date

Jun 30, 2023Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 29, 2022

First Submission Date that Met QC Criteria

Nov 29, 2022

First Posted Date

Dec 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2023

Last Update Posted Date

Sep 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Subjects that are currently on a transcutaneous carbon dioxide monitor (TCOM) to monitor the carbon dioxide level in their blood will be placed on an additional TCOM using a non-adhesive sensor application ring instead of the usual adhesive ring to hold the TCOM sensor in place in order to evaluate usability of the non-adhesive applicator.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Evaluation	Other	Evaluation of ease of use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates		3 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premature or term birth newborn infants requiring transcutaneous monitoring
Thigh circumference of greater than 63mm
Weight greater than or equal to 600g
Ability of caretaker to understand verbal and written instructions and informed consent

Exclusion Criteria:

Absence of written informed consent.
Skin condition contraindicating transcutaneous measurements.
Thigh circumference less than or equal to 63 mm

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Minutes

Maximum Age

6 Months

Standard Ages

Child

Study Population

Infants

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided