NCT06347939 Mediastinal EBUS Cryobiopsy Study In Sweden
| NCT ID | NCT06347939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Mediastinal Lymphadenopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Hemodynamically instable patient * Myocardial infarction in the last six weeks prior to participating in the study. * Life threatening arrythmia * Respiratory failure and inadequate blood oxygenation despite oxygen supply. * Tracheal obstruction of high grade. * High bleeding risk * Patient not willing to participate in the study * Patient not speaking swedish and needing translator during the procedure
Frequently Asked Questions
Who can join the NCT06347939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mediastinal Lymphadenopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06347939 currently recruiting?
Yes, NCT06347939 is actively recruiting participants. Visit ClinicalTrials.gov or contact Region Skane to inquire about joining.
Where is the NCT06347939 trial being conducted?
This trial is being conducted at Lund, Sweden, Umeå, Sweden.
Who is sponsoring the NCT06347939 clinical trial?
NCT06347939 is sponsored by Region Skane. The trial plans to enroll 200 participants.