CClinicalTrials.gg
CompletedNCT06897878OPTIBIOPUpdated Feb 4, 2026

Optimal Number of Pleural Biopsies During Pleuroscopy

An observational study in Pleural Diseases, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Icahn School of Medicine at Mount Sinai · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
104
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pleural Diseases

Keywords

  • Pleuroscopy
  • Pleural effusion
  • Pleural biopsy
03

In context

Pleural Diseases

49 studies on the registry are indexed under Pleural Diseases; 13 are open to participants now.

This study's enrollment of 104 is below the median of 152 across 14 observational studies indexed under Pleural Diseases.

Browse Pleural Diseases studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

- Inability to provide informed consent

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
104 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Pleural biopsy

    All consecutive patients referred for a pleuroscopy.

06

What researchers measure

Primary outcomes

  1. Number of pleural biopsies to reach a diagnosis

    The number of pleural biopsies needed to reach a diagnosis.

    Time frame: At week 2 after pleuroscopy

Secondary outcomes

  1. Number of pleural biopsies required for comprehensive biomarker testing.

    The number of biopsies required to obtain sufficient material for comprehensive biomarker testing.

    Time frame: At week 4 after pleuroscopy

  2. Number of complications

    Number of complications related to the biopsy.

    Time frame: At week 4 after pleuroscopy

07

Study locations

1 site
  • Mount Sinai Hospital
    New York, New York 10028, United States
08

References and documents

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06897878
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Udit Chaddha (Associate Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Mar 27, 2025
Start date
Dec 5, 2024
Primary completion
Dec 18, 2025
Completion
Dec 18, 2025
Last update
Feb 4, 2026

Study contacts

Udit Chaddha
principal investigator · MBBS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion