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NCT04801108 · ClinicalTrials.gov registry record · NA
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
A NA study of Emphysema or COPD, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04801108: Recruiting NA study of Emphysema or COPD, sponsored by Beth Israel Deaconess Medical Center.
NCT04801108 is a NA study of Emphysema or COPD that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants, below the 72-participant average among 7 other Emphysema or COPD trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04801108, a NA study of Emphysema or COPD, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for \<95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling. The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.
Primary Outcome
We will determine that we met this feasibility objective if the target inter-lobar fissure can be completed in at least 90% of the patients undergoing surgery.
Conditions Studied
Interventions
- PROCEDURE Robotic or VATS lobar fissure completion
- DEVICE Endobronchial valves placement
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2026-08-01 |
| Phase | NA |
What NCT04801108 shows while recruiting
NCT04801108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 72-participant average among 7 other Emphysema or COPD trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Emphysema or COPD appearing as the primary indexed condition, and to 2 interventions - of which Robotic or VATS lobar fissure completion is the first listed.
NCT04801108 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04801108 about?
NCT04801108 is a clinical study titled "Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema". The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients w...
What is the current status of trial NCT04801108?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2021-08-01. Estimated completion is 2026-08-01.
What conditions does trial NCT04801108 study?
This clinical trial studies the following conditions: Emphysema or COPD.
What interventions are being tested in trial NCT04801108?
The interventions under investigation include: Robotic or VATS lobar fissure completion (PROCEDURE), Endobronchial valves placement (DEVICE).
Who is sponsoring clinical trial NCT04801108?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04801108 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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