Thin EBUS Pilot Study | NCT04745962

Studies
Thin EBUS Pilot Study

NCT04745962

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Feb 2, 2026Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Lung; Node

Interventions

Slimscope

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2020Actual

Primary Completion Date

Sep 28, 2024Actual

Completion Date

Sep 28, 2024Actual

First Submitted Date

Feb 4, 2021

First Submission Date that Met QC Criteria

Feb 4, 2021

First Posted Date

Feb 9, 2021Actual

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 29, 2026

Last Update Posted Date

Feb 2, 2026Actual

Name	Class
Olympus Corporation	INDUSTRY

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single-center pilot study at the Medical University of South Carolina (MUSC) to evaluate the safety and efficacy of the TCP-EBUS scope (Thin EBUS). This study will consist of a standard of care bronchoscopy and will be followed for approximately 3 months. While the device is not FDA approved, it is the same technology but a thinner version of the SCP-EBUS bronchoscope.

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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Procedural group			Device: Slimscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slimscope	Device	Slimscope thin EBUS endoscope is inserted and used to visualize lung nodules.	Procedural group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to visualize lung nodule	Study team will determine whether or not the lung nodule was able to be visualized by the scope.	Throughout the procedure (approximately 1 hour)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to provide informed consent.
>21 years of age or older.
Target lesion(s) within the middle third of the lung, which will be determined radiographically prior to scheduling the procedure by the bronchoscopist or radiologist, or by being located at least 2 airway generations from the main carina as seen radiographically.
Target lesion(s) location documented on CT scan report.
Indicated for bronchosocpy.
Bronchoscopic procedure scheduled within 30 days of the CT scan report.

Exclusion Criteria:

Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
Currently on anticoagulation medications with INR >1.5.
Currently using DOAC and does not suspend use at least 7 days prior to the index procedure
Currently using Plavix and does not suspend use for at least 7 days prior to the index procedure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will consist of patients who are scheduled for standard of care assessment of central pulmonary nodules.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicholas J Pastis, MD	The Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	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