The aim of this study is to 1) evaluate the safety and feasibility of lung volume reduction using LTDs and 1) evaluate the effectiveness
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) To evaluate the safety of the LTD in COPD patients with heterogeneous and
homogeneous emphysema by evaluating the type and frequency of device-related
and procedure-related AE experienced during and following LTD placement through
the 3-month visit.
2) To evaluate the feasibility of the LTD in COPD patients with heterogeneous
and homogeneous emphysema by measuring the frequencies of successful and
unsuccessful intended LTD placements.
Secondary outcome
1) To investigate the change between baseline and 3 month follow up after LTD
treatment in:
- Patient reported symptoms using dedicated questionnaires (SGRQ, mMRC, CAT)
- Pulmonary function outcomes:
- 6 minute walking distance (6MWD)
- Change in treatment target lobar volume on HRCT
- Percentage of patients reaching the minimal important difference for: FEV1,
RV, 6MWD, SGRQ
Background summary
Patients suffering from severe empysema have limited treatment options. The
standard of care is aimed at symptom reduction using (inhaltion)medication and
improving exercisice tolerance and disease acceptance. There are two invasive
surgical treatments available: lung volume reduction surgery and lung
transplantation. However, only a small group of patients is eligable for either
one of these treatment options. A, less invasive, alternative is endoscopic
lung volume reduction (ELVR). To date, ELVR using one-way valves is the only
ELVR treatment option adopted into treatment guideliness. However, this
treatment is only effective in patients without contralateral ventilation
between the treatment lobe and the ipsilateral lobe. Endobronchial coils have
been studied as an ELVR treatment option, in which intact fissures is not a
requirement. The results are promising, but the response rate 1 year after
treatment is around 40-50%. The Lung Tensioning Device (LTD) is a endobronchial
implantable device and can be regarded as a second degeration design of the
endobronchial coil. The design is improved to optimize the compression of the
treated lung parts.
Study objective
The aim of this study is to 1) evaluate the safety and feasibility of lung
volume reduction using LTDs and 1) evaluate the effectiveness
Study design
This study is a single-arm, prospective, open-label, multi-center trial
Intervention
Bilateral endoscopic lung volume reduction with Free Flow Medical LTDs
Study burden and risks
Patients enrolled in the study will perform baseline testing, including
pulmonary function testing (PFT), chest HRCT, blood draw, arterial blood gas, 6
minute walking test (6MWD) and quality of life questionnaires. If a patient
fulfils the study criteria, the patient will undergo a bronchoscopic
intervention with placement of LTD(s) in one lung. Six weeks after the
bronchoscopic intervention patients visit the hospital for follow up testing.
Next, patients will undergo the second bronchoscopic intervention with
placement of LTD(s) in the other treatment lobe. After 3 months patients will
complete the endpoint follow-up assessment (PFT, HRCT, 6MWD, arterial blood gas
and questionnaires). Thereafter, patients will be followed for 6 and 12 months
after treatment. No previous studies with the LTD have been done therefore the
exact risks are unknown. The main risks are expected to equal to existing
treatments using a nitinol wire device (LVR-coil), and can be related to the
bronchoscopic placement of the LTDs and may include pneumothorax, hemoptysis,
respiratory tract infections and COPD exacerbations. Inclusion in the study may
lead to improved lung function, exercise tolerability and/or symptom relieve.
However, no perceived or measured benefit from this treatment is also possible.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of COPD
2. >= 40 years of age
3. FEV1/FVC <= 70%
4. Post-bronchodilator FEV1 <= 45% of predicted
5. Total Lung Capacity > 100% of predicted
6. Residual Volume (RV) > 175% of predicted
7. RV/TLC > 55%
8. Marked dyspnea defined by a score of >= 2 on mMRC dyspnea scale of 0-4
9. Emphysema with >= 20% destruction (-950HU) of one or more lobe(s)
10. Stopped smoking for >= 6 months prior to entering the study
11. Completed a pulmonary rehabilitation program prior to entering the study
and/or have regular (at least once a week) physiotherapy
12. Ability to read, understand and sign the informed consent form
Exclusion criteria
1. History of recurrent clinically significant respiratory infections and/or
COPD exacerbations, defined as >= 2 hospitalizations for respiratory infections
and/or COPD exacerbations during the year prior to enrolment
2. History of recurrent clinically significant respiratory infections and/or
COPD exacerbations, defined as >= 3 courses of prednisolone and/or antibiotics
for respiratory infections and/or COPD exacerbations during the year prior to
enrolment
3. Clinically significant bronchiectasis
4. Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg)
and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
5. >= 10 mg prednisone (or equivalent dose of other corticosteroids) daily
6. Inability to walk > 140 meters in 6 minutes
7. Known pulmonary hypertension defined by right ventricular systolic pressure
> 45 mmHg and/or evidence of pulmonary hypertension or right ventricular
failure on echocardiogram
8. Significant paraseptal emphysema
9. Giant bullae (>1/3 of lung volume)
10. Medical history of asthma
11. Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
12. Underwent previous treatment with thermal vapor ablation, AeriSeal,
Cryospray, endobronchial coils or endobronchial valves (if still implanted)
13. Evidence of other disease(s) that have a predicted survival of less than
one year
14. Inability to tolerate bronchoscopy under general anaesthesia
15. Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy
(such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be
permanently stopped prior to entering the study
16. Pregnant, lactating or plans to become pregnant within the study timeframe
17. Known sensitivity to drugs required to perform bronchoscopy under general
anaesthesia
18. Any other disease(s), condition(s) or habit(s) that would interfere with
completion of study and follow up assessments, would increase the risks of
bronchoscopy or assessments or in the judgment of the investigator would
potentially interfere with the treatment
19. Known Nickel, Titanium, or Nitinol allergy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04520152 |
| CCMO | NL73201.042.21 |