Data Collection With the P200TE and P200TxE | NCT05615896

Studies
Data Collection With the P200TE and P200TxE

NCT05615896

Sponsor

Optos, PLC

Status

Terminated

Last Update Posted

Mar 12, 2024Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Retinal Disease

Interventions

Imaging Session

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study is no longer required.

Expanded Access Info

Start Date

Apr 22, 2021Actual

Primary Completion Date

Apr 28, 2021Actual

Completion Date

Jun 17, 2022Actual

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Nov 8, 2022

First Posted Date

Nov 14, 2022Actual

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 8, 2024

Last Update Posted Date

Mar 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

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

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P200TxE Device First	Experimental		Device: Imaging Session
P200TE Device First	Experimental		Device: Imaging Session

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imaging Session	Device	Various scans will be captured on both devices	P200TE Device First P200TxE Device First

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of images	The primary endpoint will be the collection of OCT scans on the P200TE and P200TxE devices. The scans will be used by R&D for development of a de-noising algorithm as well as other possible developments.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Male or female volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
Volunteers who can follow the instructions by the clinical staff at the clinical site;
Volunteers who agree to participate;
Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region.

Exclusion Criteria:

Volunteers unable to tolerate ophthalmic imaging;
Volunteers with ocular media not sufficiently clear to obtain acceptable OCT images.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Consultants of Texas Research Centers		Houston	Texas	77401	United States

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