Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (IPS-I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Holaira
ClinicalTrials.gov Identifier:
NCT01483534
First received: November 29, 2011
Last updated: May 20, 2013
Last verified: May 2013

November 29, 2011
May 20, 2013
October 2011
December 2013   (final data collection date for primary outcome measure)
Primary Safety Endpoint [ Time Frame: 365 days post procedure ] [ Designated as safety issue: Yes ]
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure. [ Time Frame: To 180-days post procedure. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01483534 on ClinicalTrials.gov Archive Site
Technical Feasibility [ Time Frame: Acute ] [ Designated as safety issue: No ]
The ability to access the target treatment area and deliver RF energy to the target treatment site.
Not Provided
Not Provided
Not Provided
 
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study

The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
Device: TLD Therapy (IPS SystemTM)
Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.
Other Name: TLD Therapy, Targeted Lung Denervation Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
December 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • FEV1 30% to 60%
  • FEV1/FVC <70%
  • Prior smoker (at least 10 pack years)
  • Quit smoking for at least 6 months

Exclusion Criteria:

  • Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
  • Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
  • Pulmonary nodule requiring surgery
  • Presence of implantable electronic devices
  • Active respiratory infection within recent weeks
  • COPD exacerbation within recent weeks
  • Recent Myocardial infarction (MI)
  • Recent and unstable or life threatening arrhythmia
  • Malignancy treated with radiation or chemotherapy within the last 2 years
  • Presence or clinical diagnosis of other respiratory diseases other than COPD
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   South Africa
 
NCT01483534
CLP-001
Yes
Holaira
Holaira
Not Provided
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Centre Groningen
Holaira
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP