Pleural DiseasesNCT06964308
Thoracoscopic Pleural Biopsy in Sohag University Hospital
A study testing thoracoscopic pleural biopsy. in people with Pleural Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases
- What is being tested?
- thoracoscopic pleural biopsy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients with suspected pleural disease who have been referred for thoracoscopic pleural biopsy
- Age: Adults aged 18 years and older
- Patients should have undergone necessary preoperative evaluations, including imaging studies (e.g., chest X-ray, CT scan) that indicate a need for biopsy.
Who cannot join
- Contraindications to Thoracoscopic Biopsy: Patients with contraindications to thoracoscopic biopsy
- Infeasibility of Procedure: Patients with anatomical or physiological factors that make thoracoscopic biopsy technically unfeasible or unsafe (e.g., severe pleural adhesions or distorted anatomy).
- Alternative Diagnoses: Patients who have been definitively diagnosed with a condition that does not require thoracoscopic biopsy for further evaluation.
- Pregnancy: Pregnant women may be excluded due to potential risks to the fetus and the need for specific procedural considerations.
- Inability to Provide Consent: Patients who are unable to provide informed consent due to cognitive impairment, language barriers, or other reasons.
- Participation in Concurrent Studies: Patients currently participating in other clinical studies that could interfere with the outcomes of this study or affect their eligibility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
essam A mokhtar, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, Professor
About this study
Official title: Thoracoscopic Pleural Biopsy, Sohag University Hospital
This study aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases.
- Conditions
- Pleural Diseases
- Being tested
- thoracoscopic pleural biopsy.
- Medical subject headings
- Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopic pleural biopsy.Procedure or surgery
This intervention aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic pleural biopsy | Other | This arm aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases. Receives: Procedure: thoracoscopic pleural biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative follow up for thoracoscopic pleural biopsy in the management of pleural diseases.
return to daily activity
Measured: 3 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Oct 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Osama Yehia, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964308
- Sponsor's protocol ID
- Soh-Med--25-2-03MS
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solari E, Marcozzi C, Ottaviani C, Negrini D, Moriondo A. Draining the Pleural Space: Lymphatic Vessels Facing the Most Challenging Task. Biology (Basel). 2022 Mar 10;11(3):419. doi: 10.3390/biology11030419.
PubMed 35336793Yao X, Abd Hamid M, Sundaralingam A, Evans A, Karthikappallil R, Dong T, Rahman NM, Kanellakis NI. Clinical perspective and practices on pleural effusions in chronic systemic inflammatory diseases. Breathe (Sheff). 2020 Dec;16(4):200203. doi: 10.1183/20734735.0203-2020.
PubMed 33447289Shaikh F, Lentz RJ, Feller-Kopman D, Maldonado F. Medical thoracoscopy in the diagnosis of pleural disease: a guide for the clinician. Expert Rev Respir Med. 2020 Oct;14(10):987-1000. doi: 10.1080/17476348.2020.1788940. Epub 2020 Jul 12.
PubMed 32588676
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Pleural Biopsy, Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06964308
- Acronym / sponsor ID
- Soh-Med--25-2-03MS
- Conditions
- Pleural Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 9 May 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.
This study aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic pleural biopsy | Other | Procedure: thoracoscopic pleural biopsy.This arm aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspected pleural disease who have been referred for thoracoscopic pleural biopsy
- Age: Adults aged 18 years and older
- Patients should have undergone necessary preoperative evaluations, including imaging studies (e.g., chest X-ray, CT scan) that indicate a need for biopsy.
Key exclusion criteria (6 listed)
- Contraindications to Thoracoscopic Biopsy: Patients with contraindications to thoracoscopic biopsy
- Infeasibility of Procedure: Patients with anatomical or physiological factors that make thoracoscopic biopsy technically unfeasible or unsafe (e.g., severe pleural adhesions or distorted anatomy).
- Alternative Diagnoses: Patients who have been definitively diagnosed with a condition that does not require thoracoscopic biopsy for further evaluation.
- Pregnancy: Pregnant women may be excluded due to potential risks to the fetus and the need for specific procedural considerations.
- Inability to Provide Consent: Patients who are unable to provide informed consent due to cognitive impairment, language barriers, or other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracoscopic pleural biopsy.This intervention aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases. | Procedure or surgery | Thoracoscopic pleural biopsy |
Primary outcome
early postoperative follow up for thoracoscopic pleural biopsy in the management of pleural diseases.
Time frame: 3 days after procedure
return to daily activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 35336793Solari E, Marcozzi C, Ottaviani C, Negrini D, Moriondo A. Draining the Pleural Space: Lymphatic Vessels Facing the Most Challenging Task. Biology (Basel). 2022 Mar 10;11(3):419. doi: 10.3390/biology11030419.
- Background: PubMed 33447289Yao X, Abd Hamid M, Sundaralingam A, Evans A, Karthikappallil R, Dong T, Rahman NM, Kanellakis NI. Clinical perspective and practices on pleural effusions in chronic systemic inflammatory diseases. Breathe (Sheff). 2020 Dec;16(4):200203. doi: 10.1183/20734735.0203-2020.
- Background: PubMed 32588676Shaikh F, Lentz RJ, Feller-Kopman D, Maldonado F. Medical thoracoscopy in the diagnosis of pleural disease: a guide for the clinician. Expert Rev Respir Med. 2020 Oct;14(10):987-1000. doi: 10.1080/17476348.2020.1788940. Epub 2020 Jul 12.
Related trials for Pleural Diseases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
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.
essam A mokhtar, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracoscopic pleural biopsy. in people with Pleural Diseases, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 May 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed O Yehya, Resident (01146628670, ahmedosamayehya37@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early postoperative follow up for thoracoscopic pleural biopsy in the management of pleural diseases. (time frame: 3 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964308, which also lists 3 linked publications.
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 9 May 2025.