Health TrialsbyHealthPanel

Post-Market BTVA Registry

ConditionEmphysema or COPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUptake Medical Technology, Inc.

About this trial

Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index > or equal to 1.2 in at least one segment to be treated

Patients must be > or equal to 18 years of age

Patients are required to provide informed consent prior to inclusion in the Registry

Disqualifiers

FEV1 < 20% predicted

DLCO < 20% predicted

Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management

> 3 COPD related hospitalizations requiring antibiotics in past 12 months

Trial population

Patients with upper lobe predominant emphysema being evaluated for possible InterVapor treatment will be considered for enrollment in the Registry

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Bronchoscopic Thermal Vapor Ablation

    Device

    Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: BTVA treated patients1 intervention

Trial outcomes

Primary outcomes

1

Change in Quality of Life

Change in Quality of Life score as assessed by the SGRQ-C questionnaire

Time frame
Baseline to 24 months

Secondary outcomes

1

Serious Adverse Events

procedure and device related serious adverse events, major medical complications

Time frame
6 and 12 months
2

Change in FEV1

Change in Forced Expired Volume in 1 second

Time frame
Baseline to 12 months
3

Change in FVC

Change in Forced Vital Capacity

Time frame
Baseline to 12 months
4

Change in TLC

Change in Total Lung Capacity

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uptake Medical Technology, Inc.

Lead sponsor

Source ClinicalTrials.gov
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