PneumothoraxPhase 3UNCUTNCT03734471
Reactor Thoracostomy
A Phase 3 study testing Reactor Device and Tube thoracostomy in people with Pneumothorax and Hemothorax, run by Crozer-Keystone Health System.
Trial summary
Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Hemothorax
- What is being tested?
- Reactor Device and Tube thoracostomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Nov 2019
- 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
- Subjects age ≥ 18 years old
- Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
- Hemodynamically stable
Who cannot join
- Pregnant patients
- Prisoners
- Need for emergency thoracostomy
- Hemodynamic instability
- Respiratory distress
About this study
Official title: Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting
Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.
Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.
- Conditions
- Pneumothorax, Hemothorax
- Being tested
- Reactor Device, Tube thoracostomy
- Medical subject headings
- Pneumothorax, Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactor DeviceDevice
The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
Tube thoracostomyProcedure or surgery
Traditional chest tube placement
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | Not described Receives: Procedure: Tube thoracostomy |
| Reactor Device | Experimental | Not described Receives: Device: Reactor Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient report of pain
As measured on a 100mm VAS
Measured: During procedure
Secondary outcomes (1)
Procedure time
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crozer-Keystone Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Pescatore, Crozer-Keystone Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734471
- Sponsor's protocol ID
- 18-025
- Acronym
- UNCUT
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting
- ClinicalTrials.gov ID
- NCT03734471
- Acronym / sponsor ID
- UNCUT / 18-025
- Conditions
- Pneumothorax, Hemothorax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Crozer-Keystone Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 8 Nov 2018 (actual)
- 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.
Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.
Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Procedure: Tube thoracostomy |
| Reactor Device | Experimental | Device: Reactor Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects age ≥ 18 years old
- Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
- Hemodynamically stable
Key exclusion criteria (5 listed)
- Pregnant patients
- Prisoners
- Need for emergency thoracostomy
- Hemodynamic instability
- Respiratory distress
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 |
|---|---|---|
| Reactor DeviceThe Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity. | Device | Reactor Device |
| Tube thoracostomyTraditional chest tube placement | Procedure or surgery | Traditional |
Primary outcome
Patient report of pain
Time frame: During procedure
As measured on a 100mm VAS
1 secondary outcome
Procedure time
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reactor Device and Tube thoracostomy in people with Pneumothorax and Hemothorax, run by Crozer-Keystone Health System.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Patient report of pain (time frame: During procedure). 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 8 Nov 2018.