A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial

NCT05118269 | Terminated DMC

• 1 other identifier: CSP-2250
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.

Conditions

Emphysema

Keywords

Heterogeneous; Thermal Vapor; Ablation; Bronchoscopy; LVR; Lung Volume Reduction

Outcome Measures

Primary Outcomes (2)

• Changes in FEV1 between Treatment vs Control at 12 months

  Percentage change in Forced expiratory volume in 1 second (FEV1) compared to active comparator: Change in FEV1, percent change from baseline to 12 months in FEV1, where FEV1 is expressed in raw units of volume (mL).

  12 months

• St. George's Respiratory Questionnaire for patients with Chronic Obstructive Pulmonary Disease (SGRQ-C) changes between Treatment vs Control at 12 months

  Health-related Qualify of Life (SGRQ-C) compared to active comparator. This is calculated as change from baseline to 12 months in SGRQ-C Total Score. SGRQ-C scores range from 0 to 100. A higher score means a worse outcome.

  12 months

Secondary Outcomes (19)

• Improvement in other measures of pulmonary function- Forced Expiratory Volume, absolute change- at 12, 18 and 24 months

  12 months, 18 months, 24 months

• Improvement in other measures of pulmonary function- Forced Expiratory Volume, Percent change- at 12, 18 and 24 months

  12 months, 18 months, 24 months

• Improvement in other measures of pulmonary function- Forced Expiratory Volume, Abs, PP change- at 12, 18 and 24 months

  12 months, 18 months, 24 months

• Improvement in other measures of pulmonary function- Forced Vital Capacity(FVC) change- at 12, 18 and 24 months

  12 months, 18 months, 24 months

• Improvement in other measures of pulmonary function- Forced Vital Capacity Percent Predicted change- at 12, 18 and 24 months

  12 months, 18 months, 24 months

Study Arms (2)

Treatment plus Optimal Medical Therapy

EXPERIMENTAL

Patients will be treated with the InterVapor System and Optimal Medical Therapy

Device: Treatment plus Optimal Medical Therapy

Optimal Medical Therapy (Control)

ACTIVE COMPARATOR

Patients will be treated according to Optimal Medical Therapy

Other: Optimal Medical Therapy

Interventions

Treatment plus Optimal Medical Therapy DEVICE

Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/World Health Organization , Global Initiative for Chronic Obstructive Lung Disease (GOLD) workshop summary).

Also known as: InterVapor, BTVA

Treatment plus Optimal Medical Therapy

Optimal Medical Therapy OTHER

Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).

Optimal Medical Therapy (Control)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and ≤ 80 years old
• Heterogeneous emphysema with upper lobe predominance in at least one lung segment to be treated (defined as a Heterogeneity Index (HI) ≥ 1.2 per CT)
• Post-bronchodilator FEV1 ≥ 15% and ≤ 45% of predicted value
• Total lung capacity (TLC) ≥ 100% predicted
• Post-bronchodilator Residual volume (RV) ≥ 200% predicted
• minute walk distance (6MWD) \> 100m and ≤ 450m
• (Partial Pressure of Oxygen) PaCO2 ≤ 45 mm Hg; PaO2 \> 45 mm Hg on room air
• Non-smoking for 4 months prior to study enrollment as confirmed by:
• negative urine analysis or serum cotinine level of ≤ 10 ng/mL, or negative CO Hb test OR
• If using smoking cessation product(s) containing nicotine at screening, serum cotinine level ≤ 13.7 ng/ml (or arterial carboxyhemoglobin ≤ 2.5%)
• Optimized medical management (consistent with GOLD guidelines)
• Pharmacological:
• Long acting bronchodilator (LABA),Long-acting muscarinic antagonists (LAMA), LAMA + LABA, or LABA + ICS \> 1 year
• b. Evidence of completed Pulmonary Rehabilitation
• ≥ 6 weeks out-patient or ≥ 3 weeks in-patient within 12 months of enrollment; or,

You may not qualify if:

• DLCO \< 20% predicted
• Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
• Clinically significant bronchiectasis
• Clinically significant (greater than 4 tablespoons per day) sputum production.
• Two (2) or more COPD exacerbations or pneumonia episodes requiring hospitalization in the last year
• Evidence of active infection in the lungs at the time of procedure.
• Daily use of systemic steroids, \> 10 mg prednisolone (or equivalent) daily.
• Lung pathology of nodule not proven stable or benign
• Clinically significant pulmonary fibrosis
• Prior lung transplant, lung volume reduction surgery (LVRS), bullectomy, or lobectomy
• Prior lung volume reduction via endobronchial valves(s), coil(s), and/or polymer. Note: Patients whose endobronchial valves have been removed can be treated if: all valves removed ≥ 3 months prior to InterVapor and baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation
• Large bulla (defined as \> 1/3 volume of the lobe)
• Highly diseased upper and lower lobes in contralateral lung (%-950 HU density \>50%)
• Paraseptal emphysema in any segment targeted for treatment
• Myocardial Infarction or congestive heart failure within 6 months of screening.

Sponsors & Collaborators

• Uptake Medical Technology, Inc.: lead

Study Sites (1)

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Emphysema

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Guibert, Prof

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 1:1 ratio between treatment group and control group. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment at 12 months, once they have completed the protocol defined follow-up period.

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: November 11, 2021
• Study Start: July 21, 2023
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)