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NCT05722340
NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
Conditions: Lung Diseases, Interstitial
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 24
Sponsor: University Hospital, Montpellier
Location: France
Summary
The main objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ILD) in terms of diagnostic confidence as determined by histologists.
Eligibility Criteria
Inclusion Criteria:Patient with purported interstitial lung diseasePatient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessmentMinimum age: 18 yearsExclusion Criteria:Contra-indication for surgeryUncontrolled oesophageal gastric reflux despite optimal treatmentThoracic deformation (For example, pectus excavatum/carinatum or major scoliosis)Risk of pleural adhesion (For example, patient who has already undergone thoracic surgery)History of abnormal bleedingPredictable risk of difficult intubationBody mass index (BMI) > 30Severe cardiovascular comorbidity (For example, instable ischemic cardiomyopathy)Unable to comply with all trial procedures/visits (For example, language barriers, upcoming move of household to another region, unwillingness to schedule the required followup visits.)Protected populations according to the French Public Health Code Articles L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent.)Potential interference from another study (The patient is participating in another interventional study, or has done so in the past month, or is affected by an exclusion period stipulated by a previous study.)Non-beneficiary of the French single-payer national medical insurance systemLack of signed informed consent
Source: ClinicalTrials.gov (NCT05722340). StuddyBuddy aggregates publicly available trial information.