Pectus ExcavatumNCT04362878
Psychological Assessment of Patients With Chest Wall Deformities
An observational study of Pectus Excavatum and Pectus Carinatum, run by University of Florence at 1 site in Italy.
Trial summary
The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pectus Excavatum, Pectus Carinatum
- How many people
- 209 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2019to 30 Sep 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents coming for the first medical examination of their chest wall at the Pectus Center outpatient clinic will be invited to participate in the study. Adolescents who express their voluntary participation will be enrolled. One of their parents/caregivers is also invited to take part in the study.
Who may be able to join
- Clinical diagnosis of pectus excavatum or pectus carinatum;
- Age from 12 to 18 years old;
- High level of fluency in Italian.
Who cannot join
- Clinical diagnosis of chronic or acute disease, or presence of other conditions which could significantly influence adolescents' quality of life, mental health, body image and self-esteem;
- Diagnosis of intellectual disability or other conditions (e.g. low level of fluency in Italian) which could hinder questionnaires understanding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Mental Health, Self-esteem, Body Image and Quality of Life in Patients With Pectus Excavatum or Pectus Carinatum: Relationship With Severity and Type of the Deformity, and Patients' Age
The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life.
Read the detailed description
The study aims at providing psychological assessment (body image, self-esteem, overall mental health) and quality of life investigation of adolescents affected by chest wall deformities, in relation to the severity and type of deformity, and patients' age; identifying risk factors for psychological disorders.
The following hypotheses were tested: differences between patients with different chest wall deformities regarding body image and mental health were expected; no hypothesis on the possible results concerning the effect of the severity of deformity on each studied variable was formulated, since previous findings are unclear. Concerning age, some differences according to different age ranges were expected. Regarding risk factors for mental health problems, older age and greater body image dissatisfaction were expected to be significant risk factors for psychological problems; regarding the severity and type of deformity, results of previous studies are unclear or lacking, so no hypothesis was tested; quality of life and self-esteem variables were also tested, as previous studies showed they are significantly related to general well being and mental health in adolescents.
Adolescents coming at the outpatient clinics for the first evaluation of their chest wall and one of their parents/caregivers were enrolled. After the medical examination, patients meeting inclusion criteria are invited to participate in the study and to be assessed by a trained psychologist who administered them all questionnaires after they expressed their informed consent.
- Conditions
- Pectus Excavatum, Pectus Carinatum
- Keywords
- Pectus excavatum, Pectus carinatum, Adolescents, Psychological Assessment, Quality of life
- Medical subject headings
- Funnel Chest, Pectus Carinatum
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients with different severity indexes.
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Measured: Baseline.
Differences in mental health mean scores on the Youth Self-Report (YSR) between PE and PC patients.
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Measured: Baseline
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients in different age ranges.
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Measured: Baseline
Correlation between mental health scores on the Child Behavior Checklist (CBCL) and mental health scores on the Youth Self-Report (YSR).
The CBCL 6-18 is a questionnaire to be filled out by parents to assess social competence and behavioral and emotional problems in children and adolescents aged 6 to 18 years old; different cut-off scores are provided according to children's/adolescents' age and gender to identify scores in the normal, borderline or clinical range.
Measured: Baseline.
Secondary outcomes (13)
Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients with different severity indexes.
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Measured: Baseline.
Differences in body image mean scores on the Body Uneasiness Test (BUT) between PE and PC patients.
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Measured: Baseline.
Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients in different age ranges.
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Measured: Baseline.
Correlation among body image scores on the Body Uneasiness Test (BUT) and mental health scores on the Youth Self-Report (YSR).
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Measured: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients with different severity indexes.
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Measured: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) between PE and PC patients.
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Measured: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients in different age ranges.
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Measured: Baseline.
Correlation among self-esteem scores on the Rosenberg Self-Esteem Scale (RSES) and mental health scores on the Youth Self-Report (YSR).
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Measured: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients with different severity indexes.
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Measured: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) between PE and PC patients.
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Measured: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients in different age ranges.
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Measured: Baseline.
Correlation among quality of life scores on the Pediatric Quality of life Inventory (Peds-Ql) and mental health scores on the Youth Self-Report (YSR).
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Measured: Baseline.
Correlation between scores on Pediatric Quality of Life Inventory (parent version) and scores on Pediatric Quality of Life Inventory (early-adolescent and adolescent versions).
The Peds-Ql (parent version) is a validated tool filled out by parents of children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents' parent version and the 13-18 years old adolescents' parent version are used. Higher scores indicated a better quality of life.
Measured: One only time point, immediately after the medical examination, that requires 10 minutes for questionnaire completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start8 Oct 2019
- Primary completion28 Feb 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Meyer Children's Hospital IRCCS
- Responsible party
- Principal investigator, Daniela Graziani, University of Florence
- Investigators
- Martin Rosanna, PsyD, Study director, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362878
- Sponsor's protocol ID
- 176/2019
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li H, Jin X, Fan S, Wang D, Wu C, Pan Z, Li Y, An Y, Wang G, Dai J, Wang Q. Behavioural disorders in children with pectus excavatum in China: a retrospective cohort study with propensity score matching and risk prediction model. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):596-603. doi: 10.1093/ejcts/ezz038.
PubMed 30824916Steinmann C, Krille S, Mueller A, Weber P, Reingruber B, Martin A. Pectus excavatum and pectus carinatum patients suffer from lower quality of life and impaired body image: a control group comparison of psychological characteristics prior to surgical correction. Eur J Cardiothorac Surg. 2011 Nov;40(5):1138-45. doi: 10.1016/j.ejcts.2011.02.019. Epub 2011 Mar 25.
PubMed 21440452Luo L, Xu B, Wang X, Tan B, Zhao J. Intervention of the Nuss Procedure on the Mental Health of Pectus Excavatum Patients. Ann Thorac Cardiovasc Surg. 2017 Aug 20;23(4):175-180. doi: 10.5761/atcs.oa.17-00014. Epub 2017 Jun 16.
PubMed 28626162Hadolt B, Wallisch A, Egger JW, Hollwarth ME. Body-image, self-concept and mental exposure in patients with pectus excavatum. Pediatr Surg Int. 2011 Jun;27(6):665-70. doi: 10.1007/s00383-011-2854-z. Epub 2011 Feb 3.
PubMed 21290134Ji Y, Liu W, Chen S, Xu B, Tang Y, Wang X, Yang G, Cao L. Assessment of psychosocial functioning and its risk factors in children with pectus excavatum. Health Qual Life Outcomes. 2011 May 4;9:28. doi: 10.1186/1477-7525-9-28.
PubMed 21542911Ticchi D, Eisinger RS, Pilegaard HK, Torre M, Sesia SB, Infante M, Voulaz E, Quesada MA, Sisask M. Evaluating interest in narrative therapy for decision making about pectus excavatum treatment. Interact Cardiovasc Thorac Surg. 2018 Feb 1;26(2):271-275. doi: 10.1093/icvts/ivx308.
PubMed 29049840Wildemeersch D, Bernaerts L, D'Hondt M, Hans G. Reference Correction: Preliminary Evaluation of a Web-Based Psychological Screening Tool in Adolescents Undergoing Minimally Invasive Pectus Surgery: Single-Center Observational Cohort Study. JMIR Ment Health. 2018 Nov 12;5(4):e11608. doi: 10.2196/11608.
PubMed 30578210
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mental Health, Self-esteem, Body Image and Quality of Life in Patients With Pectus Excavatum or Pectus Carinatum: Relationship With Severity and Type of the Deformity, and Patients' Age
- ClinicalTrials.gov ID
- NCT04362878
- Acronym / sponsor ID
- 176/2019
- Conditions
- Pectus Excavatum, Pectus Carinatum
- Keywords
- Pectus excavatum, Pectus carinatum, Adolescents, Psychological Assessment, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Meyer Children's Hospital IRCCS
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 27 Apr 2020 (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.
The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life.
Detailed description
The study aims at providing psychological assessment (body image, self-esteem, overall mental health) and quality of life investigation of adolescents affected by chest wall deformities, in relation to the severity and type of deformity, and patients' age; identifying risk factors for psychological disorders.
The following hypotheses were tested: differences between patients with different chest wall deformities regarding body image and mental health were expected; no hypothesis on the possible results concerning the effect of the severity of deformity on each studied variable was formulated, since previous findings are unclear. Concerning age, some differences according to different age ranges were expected. Regarding risk factors for mental health problems, older age and greater body image dissatisfaction were expected to be significant risk factors for psychological problems; regarding the severity and type of deformity, results of previous studies are unclear or lacking, so no hypothesis was tested; quality of life and self-esteem variables were also tested, as previous studies showed they are significantly related to general well being and mental health in adolescents.
Adolescents coming at the outpatient clinics for the first evaluation of their chest wall and one of their parents/caregivers were enrolled. After the medical examination, patients meeting inclusion criteria are invited to participate in the study and to be assessed by a trained psychologist who administered them all questionnaires after they expressed their informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents coming for the first medical examination of their chest wall at the Pectus Center outpatient clinic will be invited to participate in the study. Adolescents who express their voluntary participation will be enrolled. One of their parents/caregivers is also invited to take part in the study.
Key inclusion criteria (3 listed)
- Clinical diagnosis of pectus excavatum or pectus carinatum;
- Age from 12 to 18 years old;
- High level of fluency in Italian.
Key exclusion criteria (2 listed)
- Clinical diagnosis of chronic or acute disease, or presence of other conditions which could significantly influence adolescents' quality of life, mental health, body image and self-esteem;
- Diagnosis of intellectual disability or other conditions (e.g. low level of fluency in Italian) which could hinder questionnaires understanding.
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
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients with different severity indexes.
Time frame: Baseline.
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Differences in mental health mean scores on the Youth Self-Report (YSR) between PE and PC patients.
Time frame: Baseline
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients in different age ranges.
Time frame: Baseline
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Correlation between mental health scores on the Child Behavior Checklist (CBCL) and mental health scores on the Youth Self-Report (YSR).
Time frame: Baseline.
The CBCL 6-18 is a questionnaire to be filled out by parents to assess social competence and behavioral and emotional problems in children and adolescents aged 6 to 18 years old; different cut-off scores are provided according to children's/adolescents' age and gender to identify scores in the normal, borderline or clinical range.
13 secondary outcomes
Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients with different severity indexes.
Time frame: Baseline.
Differences in body image mean scores on the Body Uneasiness Test (BUT) between PE and PC patients.
Time frame: Baseline.
Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients in different age ranges.
Time frame: Baseline.
Correlation among body image scores on the Body Uneasiness Test (BUT) and mental health scores on the Youth Self-Report (YSR).
Time frame: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients with different severity indexes.
Time frame: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) between PE and PC patients.
Time frame: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients in different age ranges.
Time frame: Baseline.
Correlation among self-esteem scores on the Rosenberg Self-Esteem Scale (RSES) and mental health scores on the Youth Self-Report (YSR).
Time frame: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients with different severity indexes.
Time frame: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) between PE and PC patients.
Time frame: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients in different age ranges.
Time frame: Baseline.
Correlation among quality of life scores on the Pediatric Quality of life Inventory (Peds-Ql) and mental health scores on the Youth Self-Report (YSR).
Time frame: Baseline.
Correlation between scores on Pediatric Quality of Life Inventory (parent version) and scores on Pediatric Quality of Life Inventory (early-adolescent and adolescent versions).
Time frame: One only time point, immediately after the medical examination, that requires 10 minutes for questionnaire completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Background: PubMed 30824916Li H, Jin X, Fan S, Wang D, Wu C, Pan Z, Li Y, An Y, Wang G, Dai J, Wang Q. Behavioural disorders in children with pectus excavatum in China: a retrospective cohort study with propensity score matching and risk prediction model. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):596-603. doi: 10.1093/ejcts/ezz038.
- Background: PubMed 21440452Steinmann C, Krille S, Mueller A, Weber P, Reingruber B, Martin A. Pectus excavatum and pectus carinatum patients suffer from lower quality of life and impaired body image: a control group comparison of psychological characteristics prior to surgical correction. Eur J Cardiothorac Surg. 2011 Nov;40(5):1138-45. doi: 10.1016/j.ejcts.2011.02.019. Epub 2011 Mar 25.
- Background: PubMed 28626162Luo L, Xu B, Wang X, Tan B, Zhao J. Intervention of the Nuss Procedure on the Mental Health of Pectus Excavatum Patients. Ann Thorac Cardiovasc Surg. 2017 Aug 20;23(4):175-180. doi: 10.5761/atcs.oa.17-00014. Epub 2017 Jun 16.
- Background: PubMed 21290134Hadolt B, Wallisch A, Egger JW, Hollwarth ME. Body-image, self-concept and mental exposure in patients with pectus excavatum. Pediatr Surg Int. 2011 Jun;27(6):665-70. doi: 10.1007/s00383-011-2854-z. Epub 2011 Feb 3.
- Background: PubMed 21542911Ji Y, Liu W, Chen S, Xu B, Tang Y, Wang X, Yang G, Cao L. Assessment of psychosocial functioning and its risk factors in children with pectus excavatum. Health Qual Life Outcomes. 2011 May 4;9:28. doi: 10.1186/1477-7525-9-28.
- Background: PubMed 29049840Ticchi D, Eisinger RS, Pilegaard HK, Torre M, Sesia SB, Infante M, Voulaz E, Quesada MA, Sisask M. Evaluating interest in narrative therapy for decision making about pectus excavatum treatment. Interact Cardiovasc Thorac Surg. 2018 Feb 1;26(2):271-275. doi: 10.1093/icvts/ivx308.
- Background: PubMed 30578210Wildemeersch D, Bernaerts L, D'Hondt M, Hans G. Reference Correction: Preliminary Evaluation of a Web-Based Psychological Screening Tool in Adolescents Undergoing Minimally Invasive Pectus Surgery: Single-Center Observational Cohort Study. JMIR Ment Health. 2018 Nov 12;5(4):e11608. doi: 10.2196/11608.
Related trials for Pectus Excavatum
RecruitingObservational study
Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain
Juvenile Idiopathic Arthritis (JIA), Fibromyalgia
Active, not recruiting
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Pain, Postoperative, Excavatum, Pectus
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
Recruiting
ES Catheter vs Cryoablation After Pectus Surgery
Pectus Excavatum
Active, not recruiting
Pectus Excavatum Camouflage (IT)
Pectus Excavatum
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.
Martin Rosanna, PsyD study director
Meyer Children's Hospital IRCCS
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 Pectus Excavatum and Pectus Carinatum, run by University of Florence at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 20 Mar 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients with different severity indexes. (time frame: Baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362878, which also lists 7 linked publications.
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 20 Mar 2023.