Lung Diseases, InterstitialNIVATS-2NCT05722340
NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
A study testing Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy and Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy in people with Lung Diseases, Interstitial, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy and Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2023to 29 Jun 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patient with purported interstitial lung disease
- Patient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessment
- Minimum age: 18 years
Who cannot join
- Contra-indication for surgery
- Uncontrolled oesophageal gastric reflux despite optimal treatment
- Thoracic 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 bleeding
- Predictable risk of difficult intubation
Show all 13Show fewer
- Body mass index (BMI) > 30
- Severe 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 system
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
Montpellier
About this study
Official title: Video-assisted Thoracic Surgery for Lung Biopsy Using Non-intubated (NIVATS) Versus Intubated General Anaesthesia (IGAVATS): a Randomized, Controlled, Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
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.
Read the detailed description
The primary 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. The experimental arm will be operated under a neoteric non-intubated video assisted thoracic surgery (NIVATS) technique and the comparator arm under a usual intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) technique.
Secondarily, the two groups will also be compared in terms of: (i) further variables associated with histology, biopsy quality and size; (ii) surgical performance, (iii) patient trajectories and lung function; (iv) quality of life, and (v) harms.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy, Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsyProcedure or surgery
An epidural anaesthesia associated with mild sedation requiring no ventilation is used.
Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsyProcedure or surgery
Uses a traditional deep anaesthesia and one-lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| NIVATS | Experimental | Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS). Receives: Procedure: Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy |
| IGAVATS | Active comparator | Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS). Receives: Procedure: Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of diagnostic confidence based on centralized histology only
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Measured: Day 1 to day 15
Secondary outcomes (39)
The level of diagnostic confidence based on routine histology only
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Measured: Day 1 to day 15
The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Measured: Day 7 to day 28
Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Measured: Day 7 to day 28
Classification according to ATS/ERS at MDA-1
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Measured: Day -28 to day -3
Classification according to ATS/ERS at MDA-2
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Measured: Day 7 to day 28
Inter-histologist concordance for ATS/ERS categories
Inter-histologist concordance for ATS/ERS categories
Measured: Day 1 to 15
Longest length (mm) of biopsy specimens
Longest length (mm) of biopsy specimens
Measured: Day 1 to 15
Volume (cc) of biopsy specimens
Volume (cc) of biopsy specimens
Measured: Day 1 to 15
Weight (g) of biopsy specimens
Weight (g) of biopsy specimens
Measured: Day 1 to 15
Numerical scale for biopsy quality
The histologist ranks biopsy quality from worst imaginable (0) to excellent (10).
Measured: Day 1 to 15
Preparation time (minutes)
Minutes lapsed between entering the surgical ward and entering the operating room (OR)
Measured: Day 0
OR time (minutes)
Minutes lapsed between entering and exiting the OR
Measured: Day 0
Recovery room (RR) time (minutes)
Minutes lapsed between exiting the OR and exiting the surgical ward.
Measured: Day 0
Post-RR time (hours)
Hours lapsed between exit from surgical ward, and discharge from hospital
Measured: Day 1 to 15
First drink time (minutes)
Minutes lapsed between application of last bandage on surgical wounds to first drink
Measured: Day 0
Post-operative fasting time (hours)
Hours lapsed between application of last bandage on surgical wounds to first meal
Measured: Day 0
Time with chest tube in place (hours)
Hours lapsed between application of last bandage on surgical wounds to removal of chest tube
Measured: Day 0
Visual analogue scale score for post-operative pain
The patient will be asked to evaluate his/her level of post-operative pain using a numeric rating scale (0-10) the morning after surgery where 0 represents no pain, and 10 represents the worse possible pain.
Measured: Day 1, morning after surgery
Patient satisfaction (satisfied vs unsatisfied)
The patient will be asked to evaluate his/her satisfaction (satisfied vs unsatisfied)
Measured: Hospital discharge (expected maximum of 15 days)
Time to dischargeability
Dischargeability is defined as meeting the following criteria: (i) satisfactory pain control via oral analgesia; (ii) ability to mobilize and return to usual autonomy; (iii) absence of clinical, laboratory and radiological complications; (iv) stable respiratory state compatible pre-surgical state and home discharge; (v) vital signs are normal for the patient; (vi) chest tube removal >12 hours.
Measured: Days 1 to 15
Length of initial hospitalization stay (hours)
Length of initial hospitalization stay (hours)
Measured: Expected maximum of 15 days
Cumulative days of hospitalization
Cumulative days of hospitalization
Measured: 12 months
Cumulative days of exacerbation
Cumulative days of exacerbation
Measured: 12 months
Days alive, not exacerbating and not in hospital
Days alive, not exacerbating and not in hospital
Measured: 12 months
Forced vital capacity (litres)
Forced vital capacity (litres)
Measured: Day -28 to Day -1
Forced vital capacity (litres)
Forced vital capacity (litres)
Measured: 12 months
Forced vital capacity (% theoretical value)
Forced vital capacity (% theoretical value)
Measured: Day -28 to Day -1
Forced vital capacity (% theoretical value)
Forced vital capacity (% theoretical value)
Measured: 12 months
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: 12 months
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: 12 months
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: 12 months
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: 12 months
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: 12 months
Presence / absence of complications
Complications will be listed and classified (Minor: (1) Any complication without need for pharmacologic treatment or other intervention; (2) Any complication that requires pharmacologic treatment or minor intervention only; Major: (3) Any complication that requires surgical, radiologic, endoscopic intervention, or multitherapy; (3a) Intervention does not require general anesthesia; (3b) Intervention requires general anesthesia; (4) Any complication requiring intensive care unit management and life support; (4a) Single organ dysfunction; (4b) Multiorgan dysfunction; (5) Any complication leading to the death of the patient.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start24 May 2023
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this prospective, parallel group, randomized (1:1), controlled, pilot trial, screening will take place during routine multidisciplinary assessment (MDA) meetings. The study is then presented to eligible patients during their next pre-surgical visits; if the patients are interested in participating, informed consent procedures are completed (again during routine visits) and the patients are randomized to two arms. In the experimental arm, patients will undergo NIVATS for lung biopsy, and in the standard arm, patients will undergo traditional IGAVATS for lung biopsy. Histology is then performed as usual, before entering a centralized pathway for a second analysis by an expert external to the study, and a second routine MDA convened (both blinded to study arms). Patients are followed-up for 12 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722340
- Sponsor's protocol ID
- RECHMPL 22_0042
- Acronym
- NIVATS-2
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data will be made available to persons who address a reasonable request to the study director. Individual participant data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. The study protocol, participant Information materials, worksheet and data sharing plan will also be made available to the public.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-assisted Thoracic Surgery for Lung Biopsy Using Non-intubated (NIVATS) Versus Intubated General Anaesthesia (IGAVATS): a Randomized, Controlled, Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT05722340
- Acronym / sponsor ID
- NIVATS-2 / RECHMPL 22_0042
- Conditions
- Lung Diseases, Interstitial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 10 Feb 2023 (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.
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.
Detailed description
The primary 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. The experimental arm will be operated under a neoteric non-intubated video assisted thoracic surgery (NIVATS) technique and the comparator arm under a usual intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) technique.
Secondarily, the two groups will also be compared in terms of: (i) further variables associated with histology, biopsy quality and size; (ii) surgical performance, (iii) patient trajectories and lung function; (iv) quality of life, and (v) harms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- In this prospective, parallel group, randomized (1:1), controlled, pilot trial, screening will take place during routine multidisciplinary assessment (MDA) meetings. The study is then presented to eligible patients during their next pre-surgical visits; if the patients are interested in participating, informed consent procedures are completed (again during routine visits) and the patients are randomized to two arms. In the experimental arm, patients will undergo NIVATS for lung biopsy, and in the standard arm, patients will undergo traditional IGAVATS for lung biopsy. Histology is then performed as usual, before entering a centralized pathway for a second analysis by an expert external to the study, and a second routine MDA convened (both blinded to study arms). Patients are followed-up for 12 months.
| Arm | Type | Receives |
|---|---|---|
| NIVATS | Experimental | Procedure: Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsyLung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS). |
| IGAVATS | Active comparator | Procedure: Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsyLung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with purported interstitial lung disease
- Patient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessment
- Minimum age: 18 years
Key exclusion criteria (13 listed)
- Contra-indication for surgery
- Uncontrolled oesophageal gastric reflux despite optimal treatment
- Thoracic 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 bleeding
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 |
|---|---|---|
| Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsyAn epidural anaesthesia associated with mild sedation requiring no ventilation is used. | Procedure or surgery | NIVATS |
| Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsyUses a traditional deep anaesthesia and one-lung ventilation | Procedure or surgery | IGAVATS |
Primary outcome
The level of diagnostic confidence based on centralized histology only
Time frame: Day 1 to day 15
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
39 secondary outcomes
The level of diagnostic confidence based on routine histology only
Time frame: Day 1 to day 15
The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2
Time frame: Day 7 to day 28
Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2
Time frame: Day 7 to day 28
Classification according to ATS/ERS at MDA-1
Time frame: Day -28 to day -3
Classification according to ATS/ERS at MDA-2
Time frame: Day 7 to day 28
Inter-histologist concordance for ATS/ERS categories
Time frame: Day 1 to 15
Longest length (mm) of biopsy specimens
Time frame: Day 1 to 15
Volume (cc) of biopsy specimens
Time frame: Day 1 to 15
Weight (g) of biopsy specimens
Time frame: Day 1 to 15
Numerical scale for biopsy quality
Time frame: Day 1 to 15
Preparation time (minutes)
Time frame: Day 0
OR time (minutes)
Time frame: Day 0
Recovery room (RR) time (minutes)
Time frame: Day 0
Post-RR time (hours)
Time frame: Day 1 to 15
First drink time (minutes)
Time frame: Day 0
Post-operative fasting time (hours)
Time frame: Day 0
Time with chest tube in place (hours)
Time frame: Day 0
Visual analogue scale score for post-operative pain
Time frame: Day 1, morning after surgery
Patient satisfaction (satisfied vs unsatisfied)
Time frame: Hospital discharge (expected maximum of 15 days)
Time to dischargeability
Time frame: Days 1 to 15
Length of initial hospitalization stay (hours)
Time frame: Expected maximum of 15 days
Cumulative days of hospitalization
Time frame: 12 months
Cumulative days of exacerbation
Time frame: 12 months
Days alive, not exacerbating and not in hospital
Time frame: 12 months
Forced vital capacity (litres)
Time frame: Day -28 to Day -1
Forced vital capacity (litres)
Time frame: 12 months
Forced vital capacity (% theoretical value)
Time frame: Day -28 to Day -1
Forced vital capacity (% theoretical value)
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
Time frame: 12 months
Presence / absence of complications
Time frame: 12 months
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 17 Jul 2026.
- Individual participant dataSharing planned: Yes. The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data will be made available to persons who address a reasonable request to the study director. Individual participant data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. The study protocol, participant Information materials, worksheet and data sharing plan will also be made available to the public.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy and Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy in people with Lung Diseases, Interstitial, run by University Hospital, Montpellier at 1 site in France.
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 13 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 17 Jul 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 France. 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?
The level of diagnostic confidence based on centralized histology only (time frame: Day 1 to day 15). 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 17 Jul 2026.