PACMAN Ultrasound Recording Data Collection | NCT03368976

Studies
PACMAN Ultrasound Recording Data Collection

NCT03368976

Sponsor

Avanos Medical

Status

Terminated

Last Update Posted

Sep 19, 2019Actual

Enrollment

767Actual

Phase

Not provided

Conditions

Anesthesia, Local

Interventions

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim Goals met. Decision made to terminate in favor of completing the study as a second protocol in the future.

Expanded Access Info

Start Date

Jul 31, 2017Actual

Primary Completion Date

Sep 17, 2019Actual

Completion Date

Sep 17, 2019Actual

First Submitted Date

Dec 6, 2017

First Submission Date that Met QC Criteria

Dec 6, 2017

First Posted Date

Dec 11, 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

Sep 18, 2019

Last Update Posted Date

Sep 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Study to collect videos of ultrasound recordings during peripheral nerve block procedures.

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

767Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interscalene
Supraclavicular
Infraclavicular
Transversus Abdominus Plane
Paravertebral Space
Fascia Iliaca
Femoral Nerve
Saphenous Nerve via Adductor Canal
Popliteal Sciatic Nerve

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of ultrasound recordings	Collection of 100 ultrasound recordings for each group	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block
Informed consent executed

Exclusion Criteria:

Patients unable to understand and provide written consent
Infection at the injection site
Allergy to local anesthetic agents
Medical condition obscuring visualization
Known neuropathy at or around target nerve for the PNB
Inability to communicate with the investigator or hospital staff

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with planned peripheral nerve block procedures.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
George Washington University		Washington D.C.	District of Columbia	20037	United States
Andrews Institute

Type	Date	Date Unknown
Release	Nov 5, 2021
Reset	Jan 3, 2022

Submission Tracking

Estimated Results First Submitted Date

Nov 5, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 5, 2021			Jan 3, 2022