Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— IPS-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483534
• Other study ID #: CLP-001
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2011
• Last updated: September 22, 2016
• Start date: October 2011
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Holaira
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics CouncilNetherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen (UMCG)	Groningen
South Africa	Stellenbosch University	Capetown
South Africa	Panorama Medi-Clinic	Panorama	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Holaira

Countries where clinical trial is conducted

Netherlands,  South Africa, 

References & Publications (1)

Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.	365 days post procedure	Yes
Secondary	Technical Feasibility	The ability to access the target treatment area and deliver RF energy to the target treatment site.	At time of Treatment	No

External Links

•   Targeted lung denervation for moderate to severe COPD: a pilot study.