Comparison of the Epifaith® Syringe With the Plastic Syringe | NCT06085027

Studies
Comparison of the Epifaith® Syringe With the Plastic Syringe

NCT06085027

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Oct 16, 2023Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Epidural; Anesthesia, Headache
Analgesia

Interventions

Labor analgesia

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2023Estimated

Primary Completion Date

Jul 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Oct 11, 2023

First Submission Date that Met QC Criteria

Oct 11, 2023

First Posted Date

Oct 16, 2023Actual

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

Oct 11, 2023

Last Update Posted Date

Oct 16, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare the efficiency of identifying epidural space with either the Epifaith® syringe or the plastic syringe in parturients. The main questions it aims to answer are:

Whether it consume less time identifying epidural space with the Epifaith® syringe
Whether the usage of the Epifaith® syringe decrease the complication rate and failure of labor analgesia Participants will receive labor analgesia either with the Epifaith® syringe or the plastic syringe conducted by experienced resident doctors.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The Epifaith® syringe	Experimental		Procedure: Labor analgesia
The plastic syringe	Active Comparator		Procedure: Labor analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Labor analgesia	Procedure	Perform epidrual analgesia for parturients between 18 to 45 year-old	The Epifaith® syringe The plastic syringe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time consumed to identify the epidural space	Starting on the moment which the syringe be attached to the needle	During the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA II to III
Require labor analgesia
Has submitted inform consent

Exclusion Criteria:

ASA IV or above
Coagulopathy
Spinal deformity
Neurological, psychological, cardiopulmonary disorder
Active liver or kidney injury

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sheng Yang, MD	Contact	+886978989351		chubbyming20@cgmh.org.tw
Rou-Yan Lin, MD	Contact	+886978989198		emily920703@cgmh.org.tw

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache
D000377	Agnosia

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided