Pneumothorax, SpontaneousPNSANCT06175416
Spontaneous Pneumothorax in Adolescents
An observational study of Pneumothorax, Spontaneous, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "The patient is usually seized with sudden chest pain and difficulty in breathing. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Pneumothorax, Spontaneous
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to Dec 2023
- Phase
- Observational
- 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 14 to 20 years
- All sexes
- Child, Adult
Study population: Patient (aged between 14-20 years old) having pontaneous pneumothorax without apparent cause and operated on at the HUS between 2010 and 2021.
Who may be able to join
- Adult patient (18-20 years old)
- Minor patient aged 14-17 years old
- Any gender
- Spontaneous pneumothorax without apparent cause, between 14 and 20 years old
- Patient operated on at the HUS between 2010 and 2021
- Patient not objecting to the reuse of their data for scientific research purposes.
- Holders of parental authority who do not object to the reuse of their child's data for scientific research purposes.
Who cannot join
- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
- Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes.
- Secondary origin of the pathology: Cystic fibrosis, postoperative pneumothorax, post-traumatic,
- Subject having been treated initially in another structure without further information.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
Isabelle TALON, MD, 33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr
Isabelle TALON, MD
About this study
Official title: Spontaneous Pneumothorax in Adolescents: Inventory and Management
Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "The patient is usually seized with sudden chest pain and difficulty in breathing.
In this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the University Hospitals of Strasbourg
- Conditions
- Pneumothorax, Spontaneous
- Keywords
- Pneumothorax, Spontaneous, Pleural cavity
- Medical subject headings
- Pneumothorax
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the management of spontaneous pneumothorax in adolescents in the Strasbourg University Hospital
This study is retrospective, the analysis focuses on the medical records of patients treated at the Strasbourg University Hospital between between January 1, 2010 and December 31, 2021.
Measured: Files analysed retrospectively from January 1, 2010 and December 31, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Sep 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax, SpontaneousStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175416
- Sponsor's protocol ID
- 8700
- Acronym
- PNSA
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2022
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Pneumothorax in Adolescents: Inventory and Management
- ClinicalTrials.gov ID
- NCT06175416
- Acronym / sponsor ID
- PNSA / 8700
- Conditions
- Pneumothorax, Spontaneous
- Keywords
- Pneumothorax, Spontaneous, Pleural cavity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Dec 2023 (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.
Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "The patient is usually seized with sudden chest pain and difficulty in breathing.
In this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the University Hospitals of Strasbourg
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patient (aged between 14-20 years old) having pontaneous pneumothorax without apparent cause and operated on at the HUS between 2010 and 2021.
Key inclusion criteria (7 listed)
- Adult patient (18-20 years old)
- Minor patient aged 14-17 years old
- Any gender
- Spontaneous pneumothorax without apparent cause, between 14 and 20 years old
- Patient operated on at the HUS between 2010 and 2021
Key exclusion criteria (4 listed)
- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
- Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes.
- Secondary origin of the pathology: Cystic fibrosis, postoperative pneumothorax, post-traumatic,
- Subject having been treated initially in another structure without further information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of the management of spontaneous pneumothorax in adolescents in the Strasbourg University Hospital
Time frame: Files analysed retrospectively from January 1, 2010 and December 31, 2021 will be examined
This study is retrospective, the analysis focuses on the medical records of patients treated at the Strasbourg University Hospital between between January 1, 2010 and December 31, 2021.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Related trials for Pneumothorax, Spontaneous
Not yet recruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Pneumothorax Spontaneous Secondary
Active, not recruiting
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Pneumothorax Spontaneous Primary
Enrolling by invitation
Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care
Pleural Diseases, Pneumothorax Spontaneous Primary
Not yet recruiting
Conservative Management in Primary Spontaneous Pneumothorax: a Multicenter Randomized Non-inferiority Study
Primary Spontaneous Pneumothorax (PSP), Conservative Management (Active Observation)
Not yet recruiting
Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, Spontaneous, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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 18 Dec 2023. 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 France. 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.
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 Isabelle TALON, MD (33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the management of spontaneous pneumothorax in adolescents in the Strasbourg University Hospital (time frame: Files analysed retrospectively from January 1, 2010 and December 31, 2021 will be examined). 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 18 Dec 2023.