Cinenses Lung Volume Reduction Reverser System First-in-man Study Treating Patients With Severe Emphysema

NCT03685526 | Unknown

• 1 other identifier: LVR-EU-FIM-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness.

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Evaluate adverse events associated with implantation of the Cinenses Lung Volume Reduction Reverser System at 3-month post final bronchoscopy. CinensesTMLung Volume Reduction Reverser System at 3-month post final bronchoscopy.

  3-month post final bronchoscopy

Secondary Outcomes (7)

• Device success (Device level)

  immediate postoperative

• Procedural success

  during the hospital stay

• St. George's Respiratory Questionnaire (SGRQ) score

  1,3,6-month,12-month follow-up

• Percent change in forced expiratory volume in 1 second

  1,3,6-month,12-month follow-up

• Decrease in the Residual Volume (RV)

  1,3,6-month,12-month follow-up

Study Arms (1)

Interventional arm

EXPERIMENTAL

Patients will be treated with Cinenses Lung Volume Reduction Reverser System.

Device: Cinenses Lung Volume Reduction Reverser System

Interventions

Cinenses Lung Volume Reduction Reverser System DEVICE

Lung Volume Reduction Reverser System is show as figure 1-4, consists of lung volume reduction reverser (short as: reverser), conveyor, measuring guide wire and transporting sheath. Matrix of reverser is nickel titanium alloy, its surface is coated by polymer flexible film, at the end of the connection segment is specially designed connector, which is easy for the reverser's transport and recycling. The silica gel part at the far end of reverser makes it softer.

Interventional arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Patient between 50 to 80 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient between 50 to 80 years old
• High Resolution CT scan indicates homogeneous or heterogeneous emphysema.
• Patient has post- bronchodilator FEV1 less than or equal to 45% of predicted
• Total Lung Capacity \> 100% of predicted.
• Residual volume≥ 200% of predicted.
• Patient has marked dyspnea scoring \>2 on mMRC scale of 0-4.
• Patient has stopped smoking for a minimum of 8 weeks prior to entering the study, as confirmed by COHb ≤2.5%
• Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form.
• Subject has completed a pulmonary rehab within the last year and/or performs regularly physical activity.
• Candidates will be excluded from the study if any of the following conditions are present:
• Patient has a change in FEV1 \> 20% post-bronchodilator
• Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months.
• Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure\>50mmHg and/or evidenced by echocardiogram.
• Patient has an inability to walk \>140 meters (150 yards) in 6 minutes.
• Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified such evidences.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, D-69126, Germany

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felix Herth

  Thoraxklinik-Heidelberg gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 26, 2018
• Study Start: May 6, 2019
• Primary Completion: October 1, 2021
• Study Completion: August 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

DE (1)