Pleural DiseasesOPTIBIOPNCT06897878
Optimal Number of Pleural Biopsies During Pleuroscopy
An observational study of Pleural Diseases, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 18 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients that undergo pleuroscopy for pleural biopsies, excluding those with inability to provide informed consent.
Who may be able to join
- Consecutive patients who require pleuroscopies will be enrolled to the study.
- Age ≥ 18
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OPTImal Number of Pleural BIOPsies During Pleuroscopy
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.
- Conditions
- Pleural Diseases
- Keywords
- Pleuroscopy, Pleural effusion, Pleural biopsy
- Medical subject headings
- Pleural Diseases, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pleural biopsy | All consecutive patients referred for a pleuroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pleural biopsies to reach a diagnosis
The number of pleural biopsies needed to reach a diagnosis.
Measured: At week 2 after pleuroscopy
Secondary outcomes (2)
Number of pleural biopsies required for comprehensive biomarker testing.
The number of biopsies required to obtain sufficient material for comprehensive biomarker testing.
Measured: At week 4 after pleuroscopy
Number of complications
Number of complications related to the biopsy.
Measured: At week 4 after pleuroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start5 Dec 2024
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Udit Chaddha, Icahn School of Medicine at Mount Sinai
- Investigators
- Udit Chaddha, Principal investigator, MBBS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897878
- Sponsor's protocol ID
- STUDY-24-01325
- Acronym
- OPTIBIOP
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImal Number of Pleural BIOPsies During Pleuroscopy
- ClinicalTrials.gov ID
- NCT06897878
- Acronym / sponsor ID
- OPTIBIOP / STUDY-24-01325
- Conditions
- Pleural Diseases
- Keywords
- Pleuroscopy, Pleural effusion, Pleural biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pleural biopsy | – | –All consecutive patients referred for a pleuroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients that undergo pleuroscopy for pleural biopsies, excluding those with inability to provide informed consent.
Key inclusion criteria (2 listed)
- Consecutive patients who require pleuroscopies will be enrolled to the study.
- Age ≥ 18
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of pleural biopsies to reach a diagnosis
Time frame: At week 2 after pleuroscopy
The number of pleural biopsies needed to reach a diagnosis.
2 secondary outcomes
Number of pleural biopsies required for comprehensive biomarker testing.
Time frame: At week 4 after pleuroscopy
Number of complications
Time frame: At week 4 after pleuroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udit Chaddha principal investigator
MBBS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Diseases, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pleural biopsies to reach a diagnosis (time frame: At week 2 after pleuroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.