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SNCTP000004396 | NCT04559464 | BASEC2021-00571

Verschluss von Fissuren mit dem AeriSeal-System zur KONVERTIERUNG des Kollateralventilationsstatus bei Patienten mit schweren Emphysemen (CONVERT-Studie)

Data source: BASEC (Imported from 07.05.2021), WHO (Imported from 18.04.2021)
Changed: 04.05.2021
Disease category: Other

Brief description of trial (Data source: BASEC)

COPD ist eine chronische Lungenerkrankung, die das Atmen erschwert. Diese kann oft verbessert werden, indem ein Ventil (das so genannte Zephyr-Ventil) in den am stärksten erkrankten Teil der Lunge implantiert wird, um die Atmung zu verbessern. Dieser Eingriff kann nicht durchgeführt werden, wenn in der Lunge offene Luftkanäle vorhanden sind, die einen Luftstrom zwischen den Lungenteilen ermöglichen.
In dieser Studie wird die Nützlichkeit eines Medizinprodukts (genannt AeriSeal-System) getestet, das diese offenen Luftkanäle verschließt und den Luftstrom zwischen den Lungenteilen stoppt. Bei Erfolg können Patienten anschließend mit dem Zephyr-Ventilen behandelt werden.

Health conditions investigated (Data source: BASEC)

COPD

Health conditions (Data source: WHO)

Emphysema;COPD;Severe Emphysema

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Das Zephyr-Ventil ist zur Behandlung von Patienten mit schwerer COPD zugelassen. Wenn das Zephyr-Ventil in den am stärksten erkrankten Teil der Lunge eingesetzt wird, verhindert es, dass eingeatmete Luft in diesen Teil der Lunge gelangt. Infolgedessen kann der gesündere Teil der Lunge besser funktionieren, was die Atmung erleichtert. Gegenwärtig kann das Zephyr-Ventil nur dann in die Lunge eingesetzt werden, wenn es keine offenen Luftkanäle zwischen den Kompartimenten gibt, in denen sich das Ventil befindet. Das bedeutet, dass dieses Ventil derzeit nicht bei Patienten mit offenen Luftkanälen eingesetzt werden kann, um die Atmung zu verbessern. Im Rahmen dieser Studie wird die Verwendung des AeriSeal-Systems zum Verschließen dieser Kanäle (wir nennen es „Fissurenverschluss“) während eines Bronchoskopieverfahrens getestet, um festzustellen, ob es eine wirksame Technik zum Verschließen der Luftkanäle zwischen Ihren Lungenhälften und zum Beseitigen des Luftstroms zwischen Ihren Lungenkompartimenten ist. Wenn der Fissurenverschluss erfolgreich ist, kann Ihr Arzt anschließend das Zephyr-Ventilverfahren zur Behandlung Ihrer COPD-Symptome durchführen. In dieser Studie werden also beide Verfahren (das AeriSeal-System und das Zephyr-Ventil) kombiniert, um die Atemfunktion zu verbessern.

Interventions (Data source: WHO)

Device: AeriSeal;Device: Zephyr Valves

Criteria for participation in trial (Data source: BASEC)

- Patienten mit bestimmten Formen der COPD
- Patienten zwischen 40 - 75 Jahre bei Studienbeginn

Exclusion criteria (Data source: BASEC)

- Patienten bei den in der Vergangenheit mit andere Verfahren zur Lungenverkleinerung behandelt wurden.
- Patient die Beatmungsunterstützung (invasiv oder nicht-invasiv) benötigen
- Rauchen

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

1. Subject is willing and able to provide Informed Consent and to participate in the
study.

2. Subject is = 40 and = 75 years of age at the time Informed Consent signature.

3. Subject has at least one lobe with = 50% emphysema destruction (at -910 HU) as
determined by QCT.

4. Subject has a diagnosis of homogenous or heterogeneous emphysema, confirmed by HRCT
scan. Heterogeneous emphysema defined as = 15% difference (at -910 HU) in emphysema
destruction score of adjacent lobes by HRCT.

5. Subject has a gap in the interlobar fissure that corresponds to one or more segments
as determined by QCT.

6. Subject has clinically significant dyspnea with a mMRC Dyspnea score = 2.

7. Subject has a Six-Minute Walk Distance = 250 meters.

8. Subject has post-bronchodilator FEV1 = 15% predicted and = 50% predicted.

9. Subject has post-bronchodilator Total Lung Capacity = 100% predicted.

10. Subject has post-bronchodilator Residual Volume = 150% predicted if heterogeneous
emphysema and = 200% predicted if homogeneous emphysema.

11. Subject has stopped smoking for at least eight (8) weeks prior to Screening visit as
confirmed by carboxyhemoglobin or cotinine levels.

12. Subject has received preventive vaccinations against potential respiratory infections
consistent with local recommendations or policy.

Exclusion Criteria:

1. Subject has severe bullous emphysema where bulla is = 1/3 of the total lung volume.

2. Subject has had prior lung volume reduction surgery, prior lobectomy or pneumonectomy,
prior lung transplantation, prior airway stent placement, prior ipsilateral
pleurodesis, or prior endobronchial lung volume reduction therapy of any type.

3. Subject has evidence of active respiratory infection.

4. Subject has an ongoing COPD exacerbation or bronchospasm.

5. Subject has a known allergy to the device components:

1. Polyether block amide - PEBAX®

2. Polyvinyl Alcohol

3. Glutaraldehyde

4. Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)

5. Silicone

6. Subject requires ventilatory support (invasive or non-invasive).

7. Subject has post-bronchodilator Diffusion Capacity (DLCO) < 20% predicted.

8. Subject cannot tolerate corticosteroids or relevant antibiotics.

9. Subject has other relevant comorbidities as judged by the Investigator or is
deconditioned and cannot tolerate the stress of post-treatment inflammatory response.

10. Subject has had three (3) or more COPD exacerbations requiring hospitalization during
the year prior to Informed Consent signature.

11. Subject has severe gas exchange abnormalities as defined by any one of the following
(test conducted at rest on room air as tolerated, or on up to 4 L/min supplemental
O2):

1. PaCO2 = 55 mm Hg (7.3 kPa)

2. PaO2 < 45 mm Hg (6.0 kPa)

3. SpO2 < 90%

12. Subject has uncontrolled pulmonary hypertension, defined as peak pulmonary systolic
pressure > 45 mm Hg on echocardiogram or right heart catheterization.

13. Subject use of systemic steroids > 20 mg/day prednisolone or equivalent within 4 weeks
of Informed Consent signature.

14. Subject use of immunosuppressive agents within four (4) weeks of Informed Consent
signature.

15. Subject whose use heparins and oral anticoagulants (e.g., warfarin, dicumarol) cannot
be discontinued according to local pre-procedural protocols. Note: antiplatelet drugs
including aspirin and clopidogrel are permitted.

16. Subject's CT scan indicates the presence of any the following radiologic
abnormalities:

1. Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply if
present for one (1) year or more without increase in size or if proven benign by
biopsy).

2. Radiologic picture consistent with active pulmonary infection, e.g., unexplained
parenchymal infiltrate.

3. Significant interstitial lung disease.

4. Significant pleural disease.

17. Subject's baseline EKG indicates non-atrial arrhythmias or conduction abnormalities.

18. Subject has high cardiac risk after undergoing cardiac risk assessment in accordance
with published guidelines or ischemic heart disease, congestive heart failure, renal
failure, or cerebrovascular disease.

19. Subject has clinically significant asthma (reversible airway obstruction), chronic
bronchitis, or bronchiectasis.

20. Subject has allergy or sensitivity to medications required to safely perform
bronchoscopy under conscious sedation or general anesthesia.

21. Subject participated in an investigational study of a drug, biologic, or device not
currently approved for marketing within 30 days prior to Screening visit. Subjects
being followed as part of a long-term surveillance of a non-pulmonary study that has
reached its primary endpoint are eligible for participation in this study.

22. Subject has Body Mass Index (BMI) < 18 kg/m2 or > 35 kg/m2.

23. Subject is a female who is pregnant, breast-feeding, or planning to be pregnant in
next 12 months.

24. Subject has clinically significant abnormal screening laboratory test results per the
Institution specific reference laboratory normal values for the following:

1. White blood cells (total)

2. Hematocrit

3. Platelets

4. Prothrombin time or INR

5. Partial thromboplastin time

6. Positive ß-HCG Pregnancy test (if female)

25. Subject has evidence of severe disease which in the judgment of the Investigator may
compromise survival for the duration of the study (at least 12 months) e.g.:

1. HIV/AIDs

2. Active malignancy

3. Stroke or Transient Ischemic attack (TIA) within 12 months of Screening visit

4. Myocardial infarction within six (6) months of the Screening visit

5. Congestive heart failure within six (6) months of the Screening visit defined as
clinical evidence of right or left heart failure or left ventricular ejection
fraction < 45% on echocardiogram

26. Subject has uncontrolled diabetes mellitus.

27. Subject has any other condition that the Investigator believes would interfere with
the intent of the study or would make participation not in the best interest of the
subject including but not limited to alcoholism, high risk for drug ab

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04559464

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04559464

Further information on trial

Date trial registered

16.09.2020

Incorporation of the first participant

15.12.2020

Recruitment status

Recruiting

Academic title (Data source: WHO)

Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema; A Multicenter, Prospective Trial

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Treated Lobe Volume Reduction (TLVR) responders;Percentage of subjects converted from a positive collateral ventilation status (CV+) to having little to no collateral ventilation (CV-) in the treated lobe.

Secundary end point (Data source: WHO)

Forced Expiratory Volume in 1 second (FEV1);Residual volume (RV)

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

France, Germany, Italy, Netherlands, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

PD Dr. med. Daniel Franzen
+41 44 255 38 28
daniel.franzen@usz.ch

Contact for general information (Data source: WHO)

Dennis McHugh;Birte Schwarz
Pulmonx Corporation
+1 925 785-5237;0201/ 433-4699
dmchugh@pulmonx.com;Birte.Schwarz@rlk.uk-essen.de

Contact for scientific information (Data source: WHO)

Dennis McHugh;Birte Schwarz
Pulmonx Corporation
+1 925 785-5237;0201/ 433-4699
dmchugh@pulmonx.com;Birte.Schwarz@rlk.uk-essen.de

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Pulmonx Corporation

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

04.05.2021

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2021-00571

Secondary ID (Data source: WHO)

630-0030-01