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Proactive treatment of collateral ventilation in CV-positive emphysema patients before EBV treatment


- candidate number21156
- NTR NumberNTR5007
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-dec-2014
- Secondary IDsNL47731.042.14 CCMO register
- Public TitleProactive treatment of collateral ventilation in CV-positive emphysema patients before EBV treatment
- Scientific TitleStudy of proactive treatment of collateral ventilation in CV-positive emphysema patients before EBV treatment
- ACRONYMMIND THE GAP
- hypothesisThe overall objective of the study is investigate if it is possible to convert CV(+) patients to CV(-) patients with use of autologeous blood or alternatively blood derived products that closes the collateral channels. And thus to develop a bronchoscopic procedure for patients with heterogeneous emphysema who have collateral flow by combining the established EBV treatment with the injection of autologeous blood or blood derived products to close of the collateral channels.
- Healt Condition(s) or Problem(s) studiedCOPD, Emphysema
- Inclusion criteria1.Diagnosis of upper or lower lobe heterogeneous emphysema with a difference in heterogeneity of 25% in destruction at -950HU between ipsilateral lobes.
2.Subjects of both genders of at least 35 years of age at the time of the baseline visit.
3.Understand and voluntarily sign a patient informed consent form.
4.15 % predicted FEV1 45% predicted.
5.RV >= 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted.
6.6MWT >= 140 meters.
7.Dyspnea score of >= 2 on the mMRC scale of 0-4.
8.Non-smoker > 8 weeks prior to signing the informed consent.
- Exclusion criteria1.Evidence of active pulmonary infection.
2.Evidence of clinically significant bronchiectasis.
3.History of more than 3 exacerbations with hospitalizations over the past 12 months.
4.Evidence of pulmonary hypertension (sPAP > 45mmHg).
5.Subject has DLCO <20% of predicted.
6.Myocardial infarction or other relevant cardiovascular events in the past 6 months.
7.Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
8.Prior endoscopic lung volume reduction.
9.Unstable pulmonary nodule requiring follow-up.
10.Pregnant or nursing women.
11.Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
12.>20mg prednisolon (or equivalent) use/days.
13.Any disease with high probability of mortality within 24 months.
14.Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins).
15.Patient was involved in other pulmonary drug studies within 30 days prior to this study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 17-nov-2014
- planned closingdate1-dec-2016
- Target number of participants20
- InterventionsThe injection of autologeous blood or blood derived products into the interlobar collateral ventilation channels region to convert CV(+) lobes into CV(-) lobes.
- Primary outcomeFeasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 1 month Follow Up.
- Secondary outcomeSafety: The number and type of procedure-related (serious) adverse events within 3 months after the procedure.

Effectiveness: Change in TLVR, lung function, exercise capacity and quality of life at 3 months Follow Up.
- Timepoints3 months follow-up after the procedure.
- Trial web sitewww.bronchoscopie.umcg.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. D.J. Slebos
- CONTACT for SCIENTIFIC QUERIESDr. D.J. Slebos
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Pulmonx Inc
- Publications
- Brief summaryTitle:
Study of proactive treatment of collateral ventilation in CV-positive emphysema patients before EBV treatment (MIND THE GAP)

Primary Objective:
1.To investigate the feasibility of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.

Secondary Objectives:
2.To investigate the safety of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
3.To investigate the effectiveness of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.

Study Design:
Prospective, single arm open label intervention study.

Study Population:
20 patients with heterogeneous emphysema and with 70-90% complete fissures detected on a CT scan.

Intervention:
The injection of autologeous blood or blood derived products into the interlobar collateral ventilation channels region to convert CV(+) lobes into CV(-) lobes.

Duration:
3 months follow-up, Study duration:24 months.

Primary endpoint:
Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 1 month Follow Up.
- Main changes (audit trail)
- RECORD15-dec-2014 - 3-apr-2015


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