MedDataX Logo

Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema

NCT ID: NCT01727037

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy (surgery to resect these bullae), however this is a major surgery with significant potential morbidity and long hospital stays. Many patients are not well enough to have this surgery, or may not wish to have it. A less invasive means of attempting to shrink the size of the bullae is to directly inject the patients' own blood into the bullae (we believe that this can lead to an inflammatory reaction leading to gradual scarring and volume loss). This can be performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding general anaesthesia).

The aim of this study is to assess the effects on lung function, quality of life measures, functional measures and CT measured lung volumes of bronchoscopic intrabullous blood instillation in patients with bullous emphysema.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bullous Emphysema

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Emphysema Chronic obstructive pulmonary disease COPD Bulla Interventional bronchoscopy Lung volume reduction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BIABI arm

Patients will undergo intrabullous autologous blood instillation

Group Type EXPERIMENTAL

Bronchoscopic intrabullous autologous blood instillation

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bronchoscopic intrabullous autologous blood instillation

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BIABI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> 35 years
* Large bulla on CT scan where bullectomy is contraindicated or is actively avoided.
* Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted
* Exertional breathlessness (mMRC \>0)
* Optimum COPD treatment for at least 6 weeks
* No COPD exacerbation for at least 6 weeks
* Fewer than 3 admissions for infective exacerbations in the preceding 12 months
* Written informed consent

Exclusion Criteria

* Inability to obtain informed consent
* Co-morbidities that would render bronchoscopy or sedation unsafe.
* Anaemia or other reasons precluding venesection.
* Clinically significant bronchiectasis
* Arrhythmia or cardiovascular disease that poses a risk during procedure
* Lung nodule requiring further investigation or treatment
* Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pallav L Shah, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Chelsea and Westminster Hospitals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust

Mansfield, Nottinghamshire,, United Kingdom

Site Status RECRUITING

The Royal Brompton and Harefield NHS Trust

London, , United Kingdom

Site Status RECRUITING

Chelsea and Westminster Hospital NHS Foundation trust

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zaid Zoumot, MBBS MRCP MSc

Role: CONTACT

Phone: +442073518029

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Samuel V Kemp, MBBs MRCP

Role: primary

Zaid Zoumot, MBBS MRCP MSc

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BIABI v1

Identifier Type: -

Identifier Source: org_study_id