Safety and Efficacy of a Device for the Relief of Pain Du... | NCT03810326

Studies
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

NCT03810326

Sponsor

Yuinvent Innovations Ltd.

Status

Unknown status

Last Update Posted

Jan 18, 2019Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Carpal Tunnel Syndrome

Interventions

CTR device (tradename named Xtend)

Countries

Israel

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2019Actual

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Jan 1, 2020Estimated

First Submitted Date

Jan 17, 2019

First Submission Date that Met QC Criteria

Jan 17, 2019

First Posted Date

Jan 18, 2019Actual

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

Jan 17, 2019

Last Update Posted Date

Jan 18, 2019Actual

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

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Device: CTR device (tradename named Xtend)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTR device (tradename named Xtend)	Device	Non invasive active splint	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in pain score	Reduction in NRS reported pain score	10 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients, above 40 years of age.
Able to understand and sign informed consent
Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
Numbness and tingling in the median nerve distribution
Nocturnal Numbness
Weakness and/or atrophy of the thenar musculature
Demonstrate positive Phalen's Test of the affected extremity
Demonstrate positive Tinel's Test of the affected extremity
Sensory impairment defined as a loss of 2-point discrimination
Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome

Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome

History of surgical carpal tunnel release
Pregnancy
Diabetes not controlled by medication
Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy
Thoracic outlet syndrome
Compromised skin integrity
Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oleg Dulcart, PHd	Contact	+972-(0)524-262544		olegd@tlvmc.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Sourasky Medical Center	Recruiting	Tel Aviv			Israel

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

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided