Pneumothorax Spontaneous SecondaryPhase 1NCT03830645
PRP in 2ry Spontaneous Pneumothorax
A Phase 1 study testing Platelet Rich Plasma in people with Pneumothorax Spontaneous Secondary, run by Zagazig University at 1 site in Egypt.
Trial summary
secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax Spontaneous Secondary
- What is being tested?
- Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2018to Dec 2020
- Phase
- Phase 1
- 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
- COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion
Who cannot join
- refusal of participation
Trial locations and contacts
1 site in 1 country.
Mohammed Walaa, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Faculty of medicine Chest Department
Zagazig, Asharqia, 44519
Ahmad Abbas, MD, 201155355369, amabbaas@zu.edu.eg
About this study
Official title: Platelet Rich Plasma in Secondary Spontaneous Pneumothorax
secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules
- Conditions
- Pneumothorax Spontaneous Secondary
- Being tested
- Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Application of platelet rich plasma through the intercostal tube into the pleural space
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma group | Experimental | Not described Receives: Biological: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air leak assessment by Cerfolio classification of the air leak by single observer
Continuous:Air leak is Present throughout the respiratory cycle Inspiratory : Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation
Measured: within 10 days after application of platelet rich plasma
physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Measured: within 10 days after application of platelet rich plasma
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Measured: one month after removal of intercostal tube
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Measured: two months after removal of intercostal tube
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Measured: three months after removal of intercostal tube
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Measured: six months after removal of intercostal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start5 Nov 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax Spontaneous SecondaryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmad Abbas, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830645
- Sponsor's protocol ID
- ZU-IRB#4931-4-11-2018
- Status last verified
- Jun 2020
- First submitted
- 27 Jan 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma in Secondary Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT03830645
- Acronym / sponsor ID
- ZU-IRB#4931-4-11-2018
- Conditions
- Pneumothorax Spontaneous Secondary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Feb 2019 (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.
secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma group | Experimental | Biological: Platelet Rich Plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion
Key exclusion criteria (1 listed)
- refusal of participation
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 |
|---|---|---|
| Platelet Rich PlasmaApplication of platelet rich plasma through the intercostal tube into the pleural space | Biological | Platelet rich plasma group |
Primary outcome
Air leak assessment by Cerfolio classification of the air leak by single observer
Time frame: within 10 days after application of platelet rich plasma
Continuous:Air leak is Present throughout the respiratory cycle Inspiratory : Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation
physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay
Time frame: within 10 days after application of platelet rich plasma
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Time frame: one month after removal of intercostal tube
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Time frame: two months after removal of intercostal tube
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Time frame: three months after removal of intercostal tube
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Time frame: six months after removal of intercostal tube
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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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.
Mohammed Walaa, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet Rich Plasma in people with Pneumothorax Spontaneous Secondary, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 1 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 30 Jun 2020. 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 Egypt. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Ahmad Abbas, MD (201155355369, amabbaas@zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air leak assessment by Cerfolio classification of the air leak by single observer (time frame: within 10 days after application of platelet rich plasma). The study lists 6 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 30 Jun 2020; AzTrials last refreshed its copy on 29 Oct 2026.