NCT06347939Recruiting
Mediastinal EBUS Cryobiopsy Study In Sweden
Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis). Follow up four weeks after the procedure to assess the risk for postoperative complications.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 29 Mar 2024
- Start date
- Apr 2024
- Primary completion date
- Apr 2026
- Lead sponsor
- Region Skane
- Diseases
- Tuberculosis, Lung cancer
- NCT number
- NCT06347939
What you commit to
- Study type: Observational
- Planned participants: 200
- From Apr 2024 to the primary completion date, Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction in the last six weeks prior to participating in the study.
Other illness
- Respiratory failure and inadequate blood oxygenation despite oxygen supply.
- High bleeding risk
Other
- Hemodynamically instable patient
- Life threatening arrythmia
- Tracheal obstruction of high grade.
- Patient not willing to participate in the study
- Patient not speaking swedish and needing translator during the procedure
Who the study is looking for
- Mediastinal lymphadenopathy with a diameter greater than 1 cm.
- Indication for assessment and sampling according to clinical praxis
- Age \> 18 years
- Patients consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Respiratory medicine and allergy department, Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Norrlands universitetssjukhus Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.