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GREENWATER 2.0: Reducing Iodinated Contrast Agents in Hospital Wastewater (GREENWATER 2)

27 maggio 2026 aggiornato da: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

GREENWATER 2.0: Cutting Edge Solution for Reducing Iodinated Contrast Agents Via Post-Administration Collection Device

The goal of this observational study is to learn if using a dedicated urine collection device after CT scans can help reduce the amount of iodinated contrast agent released into hospital wastewater in adult outpatients undergoing contrast-enhanced CT scans.

The main questions it aims to answer are:

  • Does the dedicated urine collection device improve patient acceptance and compliance with post-contrast urine collection?
  • How much iodinated contrast agent can be recovered from urine collected after CT scans?

Participants will:

  • Have their planned CT scan with iodinated contrast agent as part of their regular medical care.
  • Wait in the radiology department for about 60 minutes after the contrast injection.
  • Use a dedicated urine collection device before leaving the hospital.
  • Answer short questions about their experience with the device.

This does not change the CT scan, the contrast agent used, or the standard clinical imaging procedure. The only additional procedure is the use of the dedicated urine collection device after the scan.

Panoramica dello studio

Descrizione dettagliata

GREENWATER 2.0 is a single-center, prospective observational study with an additional urine collection procedure. The study will be conducted in the diagnostic imaging department of IRCCS Ospedale Galeazzi - Sant'Ambrogio and will include adult outpatients undergoing clinically indicated contrast-enhanced CT scans with iodinated contrast agents.

Iodinated contrast agents are widely used in CT imaging to improve diagnostic accuracy. After intravenous administration, these agents are predominantly eliminated unchanged through urine. Because conventional wastewater treatment may not fully remove iodinated contrast agent residues, urine collection shortly after contrast administration may represent a practical strategy to reduce their release into hospital wastewater.

The study builds on the previous GREENWATER study, which showed high patient willingness to participate in a sustainability-focused urine collection protocol after contrast-enhanced imaging. In GREENWATER 2.0, a dedicated urine collection device will be installed in the radiology department to make the collection process more practical and integrated into the clinical workflow.

Participants will undergo their scheduled CT scan according to standard clinical practice. The indication for the CT scan, the choice of iodinated contrast agent, the contrast dose, and the imaging protocol will not be modified for research purposes. After contrast injection, participants will be asked to remain in the radiology department for about 60 minutes and then use the dedicated urine collection device before leaving the hospital.

The study will evaluate whether this workflow is acceptable and feasible for patients in routine radiology practice. It will also assess the potential recovery of iodinated contrast agent residues from the collected urine. Additional information will be collected on the contrast agent administered, the volume of urine collected, the time between CT examination and device use, and patient-reported experience with the device, including comfort, ease of use, cleanliness, privacy, odor, waiting time perception, and clarity of instructions.

The study is expected to provide evidence on the feasibility of using a dedicated urine collection device in a hospital radiology department as a sustainability measure to reduce the environmental impact of iodinated contrast agents. The planned sample size is 416 participants, with recruitment expected to last approximately 12 months. The total study duration is expected to be approximately 18 months, including recruitment, data analysis, and preparation of the final study report.

Tipo di studio

Osservativo

Iscrizione (Stimato)

416

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: Luca Maria Sconfienza, MD, PhD
  • Numero di telefono: +390283502227
  • Email: io@lucasconfienza.it

Luoghi di studio

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult outpatients aged 18 years or older undergoing clinically indicated contrast-enhanced CT scans with iodinated contrast agents at IRCCS Ospedale Galeazzi - Sant'Ambrogio. Participants will receive standard clinical care, with no modification to the CT protocol or contrast administration. The only study-specific procedure is the post-contrast use of a dedicated urine collection device after an approximately 60-minute waiting period.

Descrizione

Inclusion Criteria:

Adult patients aged 18 years or older. Patients scheduled for a clinically indicated contrast-enhanced CT scan with iodinated contrast agent.

Patients able to provide written informed consent. Patients willing to wait approximately 60 minutes after contrast injection before using the dedicated urine collection device.

Exclusion Criteria:

Patients unable to use the dedicated urine collection device for urine collection.

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

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Adult Outpatients Undergoing Contrast-Enhanced CT
Adult outpatients scheduled for clinically indicated contrast-enhanced CT scans with iodinated contrast agents. Participants will undergo their standard CT examination with no change to the imaging protocol or contrast administration. After contrast injection, they will be asked to wait approximately 60 minutes in the radiology department and then use a dedicated urine collection device before leaving the hospital.
A dedicated urine collection device installed in the radiology department for use after contrast-enhanced CT scans. Participants will undergo their CT scan according to standard clinical practice, with no change to the imaging protocol, contrast agent selection, or contrast administration. After iodinated contrast injection, participants will be asked to wait approximately 60 minutes and then use the dedicated device before leaving the hospital. The collected urine will be used to assess the potential recovery of iodinated contrast agent residues and the feasibility of this workflow in routine radiology practice.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Acceptance and Compliance With Post-Contrast Urine Collection
Lasso di tempo: At the time of the CT examination, up to 60 minutes after contrast injection
Proportion of eligible participants who agree to participate in the study and complete the post-contrast urine collection procedure using the dedicated urine collection device after contrast-enhanced CT.
At the time of the CT examination, up to 60 minutes after contrast injection

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Potential Recovery of Iodinated Contrast Agent From Collected Urine
Lasso di tempo: At the time of the CT examination, up to 60 minutes after contrast injection
Amount or proportion of iodinated contrast agent recovered from urine collected using the dedicated urine collection device after contrast-enhanced CT, based on the administered contrast agent and urine analysis.
At the time of the CT examination, up to 60 minutes after contrast injection

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

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 (Effettivo)

10 marzo 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

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 .

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