NCT01334307

Brief Summary

The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

3.3 years

First QC Date

April 1, 2011

Last Update Submit

July 15, 2021

Conditions

Emphysema

Keywords

EmphysemaRePneu

Outcome Measures

Primary Outcomes (1)

  • St. George's Respiratory Questionnaire (SGRQ)

    The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.

    three month Follow-Up Visit

Study Arms (2)

Lung Volume Reduction Coil (LVRC)

EXPERIMENTAL

Lung Volume Reduction Coil (LVRC)

Device: Lung Volume Reduction Coil (LVRC) (PneumRx)

Control

PLACEBO COMPARATOR

Standard of Care

Device: Control

Interventions

Lung Volume Reduction Coil (LVRC) (PneumRx)DEVICE

Lung Volume Reduction Coil (LVRC)

Also known as: LVRD
Lung Volume Reduction Coil (LVRC)
ControlDEVICE

Standard of Care

Also known as: LVRC Control treatment is Standard of Care
Control

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient greater than or equal to 35 years of age
  • High resolution CT scan indicates unilateral or bilateral emphysema
  • High resolution CT scan indicates homogeneous or heterogeneous emphysema
  • Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
  • Total Lung Capacity greater than 100% predicted
  • Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
  • Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
  • Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

You may not qualify if:

  • Patient has a change in FEV1 greater than 20% post-bronchodilator
  • Patients DLCO less than 20% predicted
  • Patient has a history of recurrent clinically significant respiratory infection
  • Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
  • Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
  • Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
  • Patient is pregnant or lactating
  • Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
  • Patient has clinically significant bronchiectasis
  • Patient has giant bullae greater than 1/3 lung volume
  • Patient has had previous LVR surgery, lung transplant or lobectomy
  • Patient has been involved in other pulmonary drug studies with 30 days prior to this study
  • Patient is taking greater than 20 mg prednisone (or similar steroid) daily
  • Patient is on Plavix or has not been weaned off prior to procedure
  • Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Glasgow, United Kingdom

Location

Chelsea and Westminster Hospital

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Related Publications (2)

  • Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL. Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial. PLoS One. 2015 Apr 8;10(4):e0122656. doi: 10.1371/journal.pone.0122656. eCollection 2015.

    PMID: 25853697DERIVED

  • Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.

    PMID: 24429129DERIVED

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pallav Shah, MD

    Chelsea and Westminster Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 13, 2011

Study Start

February 1, 2010

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

GB(3)