Optimal Number of Pleural Biopsies During Pleuroscopy | NCT06897878

Studies
Optimal Number of Pleural Biopsies During Pleuroscopy

NCT06897878

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Feb 4, 2026Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Pleural Diseases

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

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

Dec 5, 2024Actual

Primary Completion Date

Dec 18, 2025Actual

Completion Date

Dec 18, 2025Actual

First Submitted Date

Mar 20, 2025

First Submission Date that Met QC Criteria

Mar 20, 2025

First Posted Date

Mar 27, 2025Actual

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

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Udit Chaddha, Associate Professor, Icahn School of Medicine at Mount SinaiPrincipal Investigator

Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

Collaborators

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A single-center, non-randomized, prospective observational, pilot study designed to determine what is the optimal number of pleural biopsies to take during pleuroscopy.

Detailed Description

After enrollment, participants will undergo pleural biopsies via pleuroscopy. Specimens will be divided into three aliquots (1-3, 4-6, 7-10), which will be sent to pathology. A designated pathologist will evaluate the specimens in each aliquot to determine the number of biopsies required to reach a diagnosis and to obtain sufficient material for biomarker testing (when needed), and determine whether analysis of further aliquots is needed.

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

Retention

Enrollment

104Actual

Label	Type	Description	Intervention Names
Pleural biopsy		All consecutive patients referred for a pleuroscopy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of pleural biopsies to reach a diagnosis	The number of pleural biopsies needed to reach a diagnosis.	At week 2 after pleuroscopy

Secondary Outcomes

Measure	Description	Time Frame
Number of pleural biopsies required for comprehensive biomarker testing.	The number of biopsies required to obtain sufficient material for comprehensive biomarker testing.	At week 4 after pleuroscopy
Number of complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients who require pleuroscopies will be enrolled to the study.
Age ≥ 18

Exclusion Criteria:

- Inability to provide informed consent

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

All adult patients that undergo pleuroscopy for pleural biopsies, excluding those with inability to provide informed consent.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Udit Chaddha	MBBS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital		New York	New York	10028	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All of the individual participant data collected during the trial, after deidentification.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Immediately following publication. No end date.

Access Criteria

Anyone who wishes to access the data. Any purpose. Proposals should be directed to jeeyune.bahk@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010995	Pleural Diseases
D010996	Pleural Effusion

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided