Registry of InterVapor™ for the Treatment of Emphysema
This study is currently recruiting participants.
Verified October 2012 by Uptake Medical Corp
Sponsor:
Uptake Medical Corp
Information provided by (Responsible Party):
Uptake Medical Corp
ClinicalTrials.gov Identifier:
NCT01719263
First received: October 26, 2012
Last updated: October 29, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial is a patient registry which has been established to obtain post-marketing clinical follow-up on patients who will receive endoscopic thermal vapor ablation treatment (InterVapor) as prescribed by their physicians. The study objectives are to prospectively document changes in lung function, dyspnea, and quality of life and to monitor serious adverse events after treatment.
| Condition |
|---|
|
Emphysema COPD |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Registry of InterVapor™ in the Treatment of Upper Lobe Predominant Emphysema |
Resource links provided by NLM:
Further study details as provided by Uptake Medical Corp:
Primary Outcome Measures:
- change in pulmonary function [ Time Frame: Months 1, 3, 6, 12, 24, 36 ] [ Designated as safety issue: No ]Change in spirometry and/or lung volume measurements from baseline to months 1,3,6,12,24, and 36
Secondary Outcome Measures:
- change in dyspnea and quality of life [ Time Frame: Months 1, 3, 6, 12, 24, 36 ] [ Designated as safety issue: No ]change in modified MRC (mMRC) dyspnea scale, COPD assessment test (CAT), EQ-5D questionnaire from baseline to months 1,3,6,12,24, and 36
- serious adverse events [ Time Frame: Weeks 1, 2, 3, Months 1, 3, 6, 12, 24, 36 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 175 |
| Study Start Date: | June 2012 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with heterogeneous emphysema with upper lobe predominance that have been prescribed InterVapor under usual care
Criteria
Inclusion Criteria:
- heterogeneous emphysema with upper lobe predominance
Exclusion Criteria:
- lower lobe predominate or homogeneous emphysema
- forced expiratory volume in 1 second (FEV1) < 20% predicted
- DLCO < 20% predicted or unmeasureable
- current or recent smoking
- arterial blood gas levels of PaO2 < 50 mmHg or PaCO2 > 55 mmHg
- active or recent respiratory infection
- history of asthma
- clinically significant chronic bronchitis or bronchiectasis
- significant cachexia or obesity
- pneumothorax or pleural effusions in the preceding 6 months
- presence of single large bulla > 1/3 volume of lobe to be treated
- known pulmonary hypertension
- known coagulopathy or current use of anticoagulants
- known sensitivity to medications required to perform bronchoscopy
- previously treated with the InterVapor system in the same lobe area(s)
- patients with an implant currently in a lung (valves, coils, sealants)
- indwelling pacemaker or implantable cardiac defibrillator
- concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor
- patients with an estimated life expectancy of less than 18 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719263
Contacts
| Contact: Steven Kesten, MD | (949)440-1774 | skesten@uptakemedical.com |
Locations
| Germany | |
| Charité Universitätsmedizin Berlin | Recruiting |
| Berlin, Germany | |
| Contact: Christian Witt, MD | |
| Principal Investigator: Christian Witt, MD | |
| Gemeinschaftskrankenhaus Havelhöhe | Recruiting |
| Berlin, Germany | |
| Contact: Christian Grah, MD | |
| Principal Investigator: Christian Grah, MD | |
| Klinik Donaustauf | Recruiting |
| Donaustauf, Germany | |
| Contact: Michael Pfeifer, MD | |
| Principal Investigator: Michael Pfeifer, MD | |
| Klinikum Fürth | Recruiting |
| Fürth, Germany | |
| Contact: Heinrich Worth, MD | |
| Principal Investigator: Heinrich Worth, MD | |
| Asklepios-Fachkliniken München-Gauting | Recruiting |
| Gauting, Germany | |
| Contact: Wolfgang Gesierich, MD | |
| Principal Investigator: Wolfgang Gesierich, MD | |
| Uniklinik Halle | Recruiting |
| Halle, Germany | |
| Contact: Bernd Schmidt, MD | |
| Principal Investigator: Bernd Schmidt, MD | |
| Klinikum Oststadt-Heidehaus | Recruiting |
| Hannover, Germany | |
| Contact: Wolf Harms, MD | |
| Principal Investigator: Bernd Schönhofer, MD | |
| Asklepios Klinik Harburg | Recruiting |
| Harburg, Germany | |
| Contact: Christoph Petermann, MD | |
| Principal Investigator: Christoph Petermann, MD | |
| Thoraxklinik, University of Heidelberg | Recruiting |
| Heidelberg, Germany | |
| Contact: Felix JF Herth, MD | |
| Principal Investigator: Felix JF Herth, MD | |
| Lungenklinik Hemer | Recruiting |
| Hemer, Germany | |
| Contact: Franz Stanzel, MD | |
| Principal Investigator: Franz Stanzel, MD | |
| Augusta Krankenanstalten & EVK Herne | Recruiting |
| Herne, Germany | |
| Contact: Erich Hecker, MD | |
| Principal Investigator: Erich Hecker, MD | |
| Lungenfachklinik Immenhausen | Recruiting |
| Immenhausen, Germany | |
| Contact: Peter Hammerl, MD | |
| Principal Investigator: Peter Hammerl, MD | |
| Sana Klinik Lübeck | Recruiting |
| Lübeck, Germany | |
| Contact: Tahsin Balli, MD | |
| Principal Investigator: Tahsin Balli, MD | |
| Klinikum München-Harlachingen | Recruiting |
| München, Germany | |
| Contact: Christian Heintz, MD | |
| Principal Investigator: Christian Heintz, MD | |
| Klinikum Nürnberg | Recruiting |
| Nürnberg, Germany | |
| Contact: Manfred Wagner, MD | |
| Principal Investigator: Manfred Wagner, MD | |
| Universitätsklinikum Tübingen | Recruiting |
| Tübingen, Germany | |
| Contact: Jürgen Hetzel, MD | |
| Principal Investigator: Jürgen Hetzel, MD | |
Sponsors and Collaborators
Uptake Medical Corp
Investigators
| Principal Investigator: | Felix JF Herth, MD | University of Heidelberg |
More Information
No publications provided
| Responsible Party: | Uptake Medical Corp |
| ClinicalTrials.gov Identifier: | NCT01719263 History of Changes |
| Other Study ID Numbers: | CSP-1343 |
| Study First Received: | October 26, 2012 |
| Last Updated: | October 29, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Uptake Medical Corp:
|
emphysema COPD lung volume reduction bronchoscopic |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Pulmonary Disease, Chronic Obstructive Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on May 19, 2013