Evidence map›Paper›PMID 31743933›Full record

ArticleRespiration; international review of thoracic diseases

Protocol of a Randomized Controlled Study of the PneumRx Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema (ELEVATE).

Felix J F Herth, Dirk-Jan Slebos, Pallav L Shah, Martin Hetzel, Gerald Schmid-Bindert, Adam S LaPrad, Gaëtan Deslée, Arschang Valipour

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Respiration; international review of thoracic diseases. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Bronchoscopic endobronchial valves.Breathe (Sheffield, England) · 2026
    Review
  3. Review
  4. Airway granulation response to lung-implantable medical devices: a concise overview.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  5. Article
  6. Bronchoscopic lung volume reduction: status quo.Annals of translational medicine · 2020
    Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 5 countries.

Felix J F HerthThoraxklinik and Translational Lung Research Center (TLRC), University of Heidelberg, Heidelberg, Germany.
Dirk-Jan SlebosDepartment of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Pallav L ShahRoyal Brompton Hospital and Chelsea and Westminster Hospital, London, United Kingdom.
Martin HetzelKrankenhaus vom Roten Kreuz, Stuttgart, Germany.
Gerald Schmid-BindertPneumRx GmbH, a BTG International Group Company, Mannheim, Germany.
Adam S LaPradPneumRx, Inc., a BTG International Group Company, Santa Clara, California, USA.
Gaëtan DesléeUniversity Hospital of Reims, INSERM U1250, Reims, France.
Arschang ValipourKarl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Department of Respiratory and Critical Care Medicine, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria, arschang.valipour@wienkav.at.
Heidelberg University · DEInserm · FRKarl Landsteiner Society · ATKrankenhaus vom Roten Kreuz · DERoyal Brompton Hospital · GBUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe PneumRx endobronchial coil system for patients with severe emphysema has been shown to improve quality of life, exercise capacity, and pulmonary function in patients with emphysema. A post hoc analysis of the RENEW trial has identified patient characteristics and lobar selection methods associated with improved outcomes, which have to be confirmed prospectively.

methodsThe ELEVATE trial is a prospective, multicenter, open label, randomized (2:1), controlled trial comparing outcomes in patients treated with endobronchial coils (treatment) to a medically managed control group (control). The trial aims to enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema. Control patients will be eligible to crossover to coil treatment after 6 months of follow-up. The co-primary effectiveness endpoints are percent change in forced expiratory volume in 1 s and quality of life measured by change in St. George's Respiratory Questionnaire from baseline to 6 months. Secondary objectives are determination of responder rates of clinical endpoints and mean change in other functional and physiologic endpoints. All patients will be followed for 24 months after initial treatment. Adverse events will be collected on an ongoing basis throughout the trial. DISCUSSION: The primary objective of the ELEVATE trial is to prospectively confirm the safety and effectiveness profile of the coil system for the treatment of severe emphysema in consideration of the findings of previous randomized controlled trials. Secondary objectives are the determination of responder rates in all clinical endpoints and mean change in physiologic endpoints.

Indexed as

Quality of LifeBronchoscopyConservative TreatmentDisease ManagementEmphysemaFemaleHumansMaleMulticenter Studies as TopicPneumonectomyPrognosisProspective StudiesRandomized Controlled Trials as TopicRespiratory Function TestsRisk AssessmentSeverity of Illness IndexBronchoscopyEmphysemaEndobronchial coilsLung volume reduction

Identifiers

PMID31743933
PMCPMC6979432
OpenAlexW2989784839

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.