ZipLine Incision Approximation Verses Suture:ZIPS3 Physic... | NCT03201536

Studies
ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

NCT03201536

Sponsor

ZipLine Medical Inc.

Status

Withdrawn

Last Update Posted

Jun 28, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Wounds and Injuries

Interventions

conventional Suture
Zip3

Countries

United States

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

May 21, 2012

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 28, 2017Actual

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

Jun 26, 2017

Last Update Posted Date

Jun 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.

Detailed Description

The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sutures	Active Comparator	zipLine3 device verses conventional sutures	Device: conventional Suture
Zip3 Device	Active Comparator		Device: Zip3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conventional Suture	Device	Sutures	sutures	stitches,PeriStrips

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound healing	Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale	3-month

Secondary Outcomes

Measure	Description	Time Frame
time of procedure	Time it takes to use device	immediately

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between 18 and 75 years of age
- In generally good health
- Willing to be evaluated in 5-14 days and 3-months post op
Patient requiring a non-emergent skin incision or biopsy
- Maximum excision size 1.5x3.0 cm
- Requiring 4-0 or smaller suture for closure
- In area of body trunk or extremities with low mobility and tension

Exclusion Criteria:

Facial Incisions or incisions in high stress or tension areas
Previously diagnosed peripheral vascular disease
Insulin-dependent diabetes mellitus
Known bleeding diathesis
Known personal or family history of keloid formation or scar hypertrophy
Known allergy or hypersensitivity to adhesives
Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
Atrophic skin deemed clinically prone to blistering
Any skin disorder affecting wound healing
Incisions requiring dermal sutures
Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian M Parret, MD	Plastic Surgery Institute of Northern California	Principal Investigator
Landon Clark, MD,MPH	Palo Alto Medical Foundation	Principal Investigator
Stanley P Leong, MD,FACS	California Pacific Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Palo Alto Medical Foundation		Palo Alto	California	94301	United States
Plastic Surgery Institute of Northern California