- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07750301
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families. (The HADAS)
1 agosto 2026 aggiornato da: Eva Maria Leon Zarceño, Universidad Miguel Hernandez de Elche
A Program for the Prevention of ED in Adolescent Female Athletes, the HADAS: Protocol for a Randomized Controlled Trial Study
Adolescent female athletes in aesthetic sports disciplines (such as rhythmic gymnastics, artistic gymnastics, synchronized swimming, and figure skating) face a complex interaction between general sociocultural beauty pressures and sport-specific aesthetic demands (e.g., the 'slim to win' culture and weight-focused performance expectations).
These combined pressures significantly increase their risk of developing body dissatisfaction and eating disorders (EDs).
To address these systemic vulnerabilities, the HADAS Program (Habits, Eating, Sports, Adolescents, and Health) was developed as a multi-level, synchronized psychoeducational intervention designed to target the complete "sports triangle": adolescent female athletes, their technical coaches, and their immediate family members.
The primary objective of this cluster randomized controlled trial (cluster RCT) is to evaluate the efficacy of the HADAS Program in reducing eating disorder risk (EAT-26) and body image dissatisfaction (BSQ-34) among competitive adolescent female athletes aged 12 to 16 years.
Sports clubs are randomly assigned to either the Experimental Group (receiving the HADAS intervention) or a Waitlist Control Group (maintaining standard training).
The program includes 5 interactive group sessions for athletes, 4 reflective workshops for coaches, and 2 structured sessions for family members, all supported by cohort-specific workbooks.
Outcomes are evaluated across four longitudinal time points: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
236
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Eva María León Zarceño
- Numero di telefono: +34 606501888
- Email: eleon@umh.es
Backup dei contatti dello studio
- Nome: Josué López Pozo
- Numero di telefono: +34 616510686
- Email: josue.lopezp@umh.es
Luoghi di studio
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Alicante
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Elche, Alicante, Spagna, 03202
- Universidad Miguel Hernández de Elche - Department of Behavioral Sciences and Health
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Contatto:
- Eva María León Zarceño
- Numero di telefono: +34 96 665 8823
- Email: eleon@umh.es
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Athletes: Female gender; aged between 12 and 16 years old; actively possessing a formal federation license in an aesthetic sport discipline (e.g., rhythmic gymnastics, artistic gymnastics, synchronized swimming, figure skating) within Spain; providing signed informed assent concurrently with written informed consent from parents/legal representatives; and presenting no active, formal clinical diagnosis of an eating disorder (ED).
- Coaches: Serving as a primary trainer or technical staff member within the participating sports club; and providing written informed consent.
- Family Members: Operating as the primary parent, guardian, or legal representative of an included athlete; and providing written informed consent.
Exclusion Criteria:
- Athletes: Presenting a current, formal clinical diagnosis of an eating disorder (e.g., Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, or ARFID) at baseline (T0); or refusal to provide informed assent or parental consent.
- Non-compliance or failure to provide signed informed consent from coaches or primary legal guardians.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Experimental Group (HADAS Program)
Sports clubs randomly assigned to receive the multi-level HADAS Program .
The intervention is synchronized across three modalities: 5 interactive group sessions (90 min each) for adolescent female athletes, 4 reflective training sessions (90 min each) for technical coaches, and 2 structured psychoeducational workshops (120 min each) for parents/family members
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A synchronized, multi-level psychoeducational prevention program designed to target eating disorder risk and body image dissatisfaction across the sports triangle (athletes, coaches, and families).
Content focuses on media literacy, healthy life habits, emotional management, deconstructing body-weight myths in aesthetic sports, and promoting autonomy-supportive coaching and family environments
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Nessun intervento: Control Group (Waitlist)
Sports clubs randomly assigned to the control condition maintain their standard active training routines and schedule without any component of the prevention program during the 12-month study window .
They will be offered the HADAS intervention after the final longitudinal follow-up (T3)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Eating Disorder Risk and Symptomatology
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Eating Attitudes Test (EAT-26; Garner et al., 1982; Spanish validation by Rivas et al., 2010).
It assesses eating disorder risk behaviors and attitudes across 26 items.
Total scores range from 0 to 78, where higher scores indicate greater eating disorder risk and symptomatology (a worse outcome) .
Scores of 20 or higher indicate the presence of significant risk attitudes toward eating.
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Body Image Dissatisfaction
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Body Shape Questionnaire (BSQ-34; Cooper et al., 1987; Spanish validation by Raich et al., 1996).
It assesses body dissatisfaction and concern with weight and shape across 34 items.
Total scores range from 34 to 204, where higher scores indicate greater body dissatisfaction and psychological distress regarding body image (a worse outcome).
Scores are categorized into no dissatisfaction (<80), mild (80-110), moderate (111-140), and severe (>140), with moderate and severe categories indicating significant body image vulnerability.
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Psychological Well-Being
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Psychological Well-Being Scale for Youth (PWB-SF-Y; Ryff, 1989; Spanish adaptation by Stavraki et al., 2022).
It assesses well-being across 6 core dimensions using a single item per dimension.
Items are rated on a 6-point Likert scale ranging from 1 ("strongly disagree") to 6 ("strongly agree").
Total scores range from 6 to 36, where higher scores indicate greater psychological well-being and optimal psychological functioning (a better outcome)..
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Life Satisfaction
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; Spanish validation in adolescents by Atienza et al., 2003).
It assesses global cognitive judgments of one's life satisfaction across 5 items rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree").
Total scores range from 5 to 25, where higher scores indicate greater life satisfaction and positive cognitive evaluation of life (a better outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Competitive Anxiety
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Revised Competitive State Anxiety Inventory-2 (CSAI-2R; Martens et al., 1990; Spanish validation by Andrade et al., 2007).
It assesses pre-competitive state anxiety across 16 items rated on a 4-point Likert scale ranging from 1 ("not at all") to 4 ("very much").
The inventory measures three subscales: Cognitive Anxiety (5 items; scores range from 5 to 20, where higher scores indicate higher cognitive anxiety / a worse outcome), Somatic Anxiety (6 items; scores range from 6 to 24, where higher scores indicate higher somatic anxiety / a worse outcome), and Self-Confidence (5 items; scores range from 5 to 20, where higher scores indicate greater self-confidence / a better outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Perfectionism in sports
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Multidimensional Inventory of Perfectionism in Sport (MIPS; Stoeber et al., 2006; Spanish validation by Ramírez-Muñoz et al., 2023).
It assesses sport-specific perfectionism across 10 items rated on a 6-point Likert scale ranging from 1 ("never") to 6 ("always").
The inventory yields two distinct subscales (5 items each, with total scores ranging from 5 to 30 for each subscale): Striving for Perfection (evaluates personal standards of excellence) and Negative Reactions to Imperfection (evaluates negative reactions to mistakes and sensitivity to external pressure), where higher scores reflect greater maladaptive perfectionism and a worse outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Appearance awareness on social networks
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Appearance-Related Social Media Consciousness Scale (ASMC; Choukas-Bradley et al., 2020; Spanish validation by Rojo et al., 2023).
It measures the ongoing awareness and body monitoring of one's physical appearance in social media contexts across 13 items rated on a 7-point Likert scale ranging from 1 ("never") to 7 ("always").
Total scores range from 13 to 91, where higher scores indicate greater appearance-related social media consciousness and body surveillance (a worse outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Critical Thinking about Media
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Critical Thinking About Media Messages Scale (CTMM; Scull et al., 2010; Spanish validation by Rojo et al., 2023).
It assesses the degree to which individuals critically analyze and evaluate aesthetic and appearance-focused media messages across 6 items rated on a 6-point Likert scale ranging from 1 ("never") to 6 ("always").
Total scores range from 6 to 36, where higher scores indicate greater critical thinking toward media and social media messages (a better outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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General knowledge about nutrition in adolescents
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Questionnaire on Nutrition Knowledge for Adolescents (C.A.P.A.; Ladrón-Arana et al., 2021).
It assesses nutritional literacy and general healthy eating knowledge in adolescents across 26 multiple-choice items (with 4 response options per item).
Each correct response is awarded 1 point, yielding total scores ranging from 0 to 26, where higher scores indicate greater general nutritional knowledge and dietary literacy (a better outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Coach controlling behaviors
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Controlling Coach Behaviors Scale (CCBS; Bartholomew et al., 2010; Spanish validation by Castillo et al., 2014).
It measures athletes' perceptions of their coach's controlling interpersonal style across 15 items rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").
The scale assesses four subscales: Controlling Use of Rewards (4 items), Negative Conditional Regard (4 items), Intimidation (4 items), and Excessive Personal Control (3 items).
Total scores range from 15 to 105, where higher scores reflect higher perceived controlling behaviors from the coach (a worse outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Leadership style in sport
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the Leadership Scale for Sports (LSS; Chelladurai & Saleh, 1980; Spanish validation by Crespo et al., 1994).
It assesses perceived coaching leadership behaviors across 31 items rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("always").
The Spanish adaptation measures 4 dimensions: Relationship-Oriented Behavior (13 items), Task-Oriented Behavior (10 items), Democratic Behavior (4 items), and Autocratic Behavior (4 items).
Dimension mean scores range from 1 to 5, where higher scores in Relationship-Oriented, Task-Oriented, and Democratic behaviors reflect more supportive and adaptive leadership styles (a better outcome).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Coach Eating Disorder Literacy and Warning Signs Knowledge
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the ad hoc Coach Eating Disorder Knowledge Questionnaire, created specifically for the HADAS Program by its research group to evaluate program-specific learning objectives.
The instrument was developed and validated via a four-stage process (item generation, expert panel review, scoring design, and pilot testing).
It assesses sports-specific eating disorder (ED) literacy across 25 items structured in 5 core dimensions: (1) General multi-causal etiology (items 1-6); (2) Identification of behavioral/emotional warning signs in sports contexts (items 7-11); (3) Risk and protective factors in competitive environments (items 12-16); (4) Consequences on physical health and performance (items 17-20); and (5) Early detection and intervention protocols (items 21-25).
Items use a True/False/I Don't Know (1 point for correct responses; 0 points for others).
Total scores range from 0 to 25, where higher scores indicate higher sports-specific ED literacy and detection competence
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Parental Eating Disorder Literacy and Warning Signs Knowledge
Lasso di tempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Evaluated using the ad hoc Family Eating Disorder Knowledge Questionnaire, created specifically for the HADAS Program by its research group to align directly with the family intervention curriculum.
The instrument was developed and validated via a four-stage process (item generation, expert panel review, scoring design, and pilot testing).
It assesses family eating disorder literacy and management across 25 items structured in 5 core dimensions: (1) General ED knowledge (items 1-6); (2) Symptom identification in adolescent athletes (items 7-11); (3) Interpretation and behavioral action plans (items 12-15); (4) Risk and protective factors (items 16-19); and (5) Language, media literacy, and family role (items 20-25).
Items use a True/False/I Don't Know format (1 point for correct responses; 0 points for incorrect or 'I Don't Know' answers).
Total scores range from 0 to 25, where higher scores indicate greater parental eating disorder literacy and proactive family management skills.
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Eva María León Zarceño, Universidad Miguel Hernández de Elche
- Investigatore principale: Josué López Pozo, Universidad Miguel Hernández de Elche
- Investigatore principale: Yolanda Quiles Marcos, Universidad Miguel Hernández de Elche
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
1 ottobre 2028
Completamento dello studio (Stimato)
1 maggio 2029
Date di iscrizione allo studio
Primo inviato
28 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 agosto 2026
Primo Inserito (Effettivo)
6 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 agosto 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Segni e sintomi, Digestivo
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Aderenza e conformità al trattamento
- Comportamento sanitario
- Conformità del paziente
- Accettazione dell'assistenza sanitaria da parte del paziente
- Interventi di aderenza
- Aderenza ai farmaci
- Disturbi dell'alimentazione e dell'alimentazione
- Educazione alla salute
Altri numeri di identificazione dello studio
- DCC.ELZ.251124
- https://doi.org/10.17605/OSF.I (Identificatore di registro: Open Science Framework (OSF))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be made available to qualified researchers upon reasonable request submitted to the principal investigator.
Data sharing will be subject to ethical review, a formal data-sharing agreement, and strict compliance with European Union GDPR regulations to safeguard minor participants' confidentiality.
Periodo di condivisione IPD
Data will become available after the primary manuscript publishing the final longitudinal findings is accepted
Criteri di accesso alla condivisione IPD
Individual participant data will not be publicly shared to protect minor participants' confidentiality in compliance with GDPR and local data protection regulations.
Aggregate data and protocol materials are available upon request
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .