EmphysemaPhase 3NCT00288964
Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure
A Phase 3 study testing Hattler Respiratory Assist Catheter in people with Emphysema and Acute Respiratory Distress Syndrome, run by Alung Technologies at 1 site in United Kingdom.
Trial summary
A new artificial lung device has been developed that potentially provides added support to mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of up to 7 days, providing more time for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Hattler Respiratory Assist Catheter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes, 18 years and older
- Have a terminally ill disease process
- On maximum ventilator support
- Intubated and unconscious
- Swan Ganz in place
- Hypoxic
- Unsuitable for organ donation
Who cannot join
- Circulatory shock (< 80 mmHg) and unresponsive to drug therapy and volume replacement
- Pregnancy
- Morbid obesity > 182 kg
- Weight < 41 kg
- History of bleeding disorders with contraindication to heparin
- Have a disease process with a contraindication to heparin
- Known internal jugular or femoral vein complications or abnormalities
- Known inferior vena cava (IVC) filter in place
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, CB3 8RE
About this study
Official title: Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial
A new artificial lung device has been developed that potentially provides added support to mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of up to 7 days, providing more time for the lungs to improve.
Extrapolating from large animal data, the hypothesis is that the Hattler Catheter will be capable of providing 30% to 40% of the basal requirements of carbon dioxide exchange in a manner that is dependable and reproducible.
Read the detailed description
The Hattler Catheter Respiratory Assist Device consists of a Catheter and a drive console. The catheter consists of a bundle of polypropylene hollow fibers (approximately 1000) in 30cm or 35cm length surrounding a helium filled balloon. The balloon is similar to an Intra-Aortic Balloon, however, it is pulsed at 300 beats per minute, while IABP typically operate at 120 bpm. The hollow fibers are similar to fibers utilized in external oxygenators for cardio-pulmonary bypass. No device exists on the market in which fibers surround a balloon, and no device exists on the market in which the hollow fiber bundle is designed to be inserted into the venous system, i.e., the vena cava. External oxygenators are designed to be used in an extracorporeal circulatory loop.
The Hattler Catheter drive console provides the power to drive the helium filled balloon while removing excess oxygen and carbon dioxide from the venous system via the catheter.
- Conditions
- Emphysema, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease, Asthma, Respiratory Insufficiency
- Being tested
- Hattler Respiratory Assist Catheter
- Keywords
- balloon, fiber, respiratory, oxygenator, Heart Failure, ARDS, COPD
- Medical subject headings
- Emphysema, Respiratory Distress Syndrome, Pulmonary Disease, Chronic Obstructive, Asthma, Respiratory Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hattler Respiratory Assist CatheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective insertion and removal as measured by hemostasis
Amount of effort required for both insertion and removal
Secondary outcomes (1)
Peak gas exchange status within a maximum 7 day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startNov 2005
Why it stopped: Sponsor no longer pursuing regulatory approval of investigational device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alung Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Tsui, MD, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288964
- Sponsor's protocol ID
- 04/Q0104/125
- Status last verified
- Dec 2015
- First submitted
- 7 Feb 2006
- Last updated
- 29 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial
- ClinicalTrials.gov ID
- NCT00288964
- Acronym / sponsor ID
- 04/Q0104/125
- Conditions
- Emphysema, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease, Asthma, Respiratory Insufficiency
- Keywords
- balloon, fiber, respiratory, oxygenator, Heart Failure, ARDS, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor no longer pursuing regulatory approval of investigational device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alung TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- First posted
- 9 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new artificial lung device has been developed that potentially provides added support to mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of up to 7 days, providing more time for the lungs to improve.
Extrapolating from large animal data, the hypothesis is that the Hattler Catheter will be capable of providing 30% to 40% of the basal requirements of carbon dioxide exchange in a manner that is dependable and reproducible.
Detailed description
The Hattler Catheter Respiratory Assist Device consists of a Catheter and a drive console. The catheter consists of a bundle of polypropylene hollow fibers (approximately 1000) in 30cm or 35cm length surrounding a helium filled balloon. The balloon is similar to an Intra-Aortic Balloon, however, it is pulsed at 300 beats per minute, while IABP typically operate at 120 bpm. The hollow fibers are similar to fibers utilized in external oxygenators for cardio-pulmonary bypass. No device exists on the market in which fibers surround a balloon, and no device exists on the market in which the hollow fiber bundle is designed to be inserted into the venous system, i.e., the vena cava. External oxygenators are designed to be used in an extracorporeal circulatory loop.
The Hattler Catheter drive console provides the power to drive the helium filled balloon while removing excess oxygen and carbon dioxide from the venous system via the catheter.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both sexes, 18 years and older
- Have a terminally ill disease process
- On maximum ventilator support
- Intubated and unconscious
- Swan Ganz in place
Key exclusion criteria (8 listed)
- Circulatory shock (< 80 mmHg) and unresponsive to drug therapy and volume replacement
- Pregnancy
- Morbid obesity > 182 kg
- Weight < 41 kg
- History of bleeding disorders with contraindication to heparin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hattler Respiratory Assist Catheter | Device | – |
Primary outcome
Effective insertion and removal as measured by hemostasis
Amount of effort required for both insertion and removal
1 secondary outcome
Peak gas exchange status within a maximum 7 day study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Tsui, MD principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hattler Respiratory Assist Catheter in people with Emphysema and Acute Respiratory Distress Syndrome, run by Alung Technologies at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective insertion and removal as measured by hemostasis. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.