Evaluation of CyclaPlex Implant for Correction of First I... | NCT02727595

Studies
Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity

NCT02727595

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Apr 4, 2016Estimated

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Hallux Valgus

Interventions

CyclaPlex Implant

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

Mar 2016

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

Apr 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Mar 30, 2016

First Submission Date that Met QC Criteria

Mar 30, 2016

First Posted Date

Apr 4, 2016Estimated

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

Mar 30, 2016

Last Update Posted Date

Apr 4, 2016Estimated

Name	Class
Cycla Orthopedics Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex implant, a button and suture type implant device and instruments for the correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.

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

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CyclaPlex Implant	Experimental	Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.	Device: CyclaPlex Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CyclaPlex Implant	Device	Button and suture type implant that will be implanted between the first and second metatarsal	CyclaPlex Implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IMA Reduction	The IMA angle is measured pre-op and post-op on x-ray images using internal software. The IMA at end of study should be less than 10 degrees or a reduction of more than 5 degrees.	One year

Secondary Outcomes

Measure	Description	Time Frame
American Orthopedic Foot and Ankle Society (AOFAS) Score	General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Weight less than 100 kilos
IMA greater than 12 degrees
IMA less than 7 degrees

Exclusion Criteria:

Diabetics
Known osteoporosis
Known allergy or hypersensitivity to metals
Gout or any systemic inflammatory arthropathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rafi Herzog, BSc	Contact			rherzog@netvision.net.il

Overall Officials

Name	Affiliation	Role
Ori Hadash, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	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
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided