Cross InfectionPOLYPTRAPNCT06838312
Reuse of Polyp Traps, a Way to Approach Sustainability
An observational study of Cross Infection, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
The environmental impact of healthcare practice in the context of climate change is in the spotlight. Digestive endoscopy units are the third hospital unit that generates the most waste and environmental impact. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Cross Infection
- What is being tested?
- Reuse or dispose a polyp trap
- How many people
- 3,238 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2025to 1 Jan 2026
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 18 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients who have undergone a colonoscopy in which a polyp trap was used.
Who may be able to join
- All patients who undergo an elective colonoscopy will be recruited for the study.
- Written informed consent to participate in the study and willingness to be contacted by telephone for follow-up.
Who cannot join
- Patients who complete the colonoscopy without a polypectomy.
- Patients who complete the colonoscopy without the use of a polyp trap.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reuse of Polyp Traps, a Way to Approach Sustainability: A Multicentric Non-inferiority Study
The environmental impact of healthcare practice in the context of climate change is in the spotlight. Digestive endoscopy units are the third hospital unit that generates the most waste and environmental impact. For this reason, scientific societies advice studying and adopting more sustainable clinical practices, reconsidering current protocols for reprocessing and disinfection of single-use material. One of the devices, widely used and which generates a large amount of waste, is the polyp trap. It allows an easy recovery of the polyps removed during endoscopy. This device is discarded after a single use in some centers, and reused after washing and disinfection in others. Manufacturers recommend the single-use of the device, even there is no scientific evidence to support this action. In the investigators endoscopy unit, 3800 polyp traps are used yearly. The investigators hypothesis is that reusing the polyp catcher has similar safety to disposal after a single use, with better environmental and economic results. Objectives: To evaluate the safety of the reused and discarded after a single-use polyp trap. The investigators will assess 1) the post-colonoscopy infection rate and 2) the reliability of the anatomopathological study, 3) CO2 emissions and 4) costs of each practice. Methodology: A non-inferiority study will be carried out by observing the usual clinical practice of different centers and collecting data that suggest infection, cross-sampling and general complications. The results will be easily applicable in endoscopy units and will serve as a basis for future studies with other more controversial devices.
- Conditions
- Cross Infection
- Being tested
- Reuse or dispose a polyp trap
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reuse or dispose a polyp trapOther
Participant hospitals will be separated into two groups, according to their standard clinical practice: A) reuse or B) dispose polyp traps after a colonoscopy with polypectomy. Centres will participate with their current method of using polyp traps. Work dynamics will not change as patients will be recruited from centers that routinely reuse or dispose polyp traps.
| Study group | Role | What they receive |
|---|---|---|
| Reuse Group | patients from centres that routinely reuse polyp traps. Receives: Other: Reuse or dispose a polyp trap | |
| Single Use Group | patients from centres that dispose polyp traps after a single use. Receives: Other: Reuse or dispose a polyp trap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with symptoms suggesting infection
Did the patient present any of the following symptoms or diagnosis after the endoscopy?
- Fever
- Bacteraemia
- Bronchoaspiration / Pneumonia
- Other: Comments:
- None
Measured: Follow up at day 15
Number of infectious events related to endoscopy
Was the event related to the endoscopy procedure? Yes / Probably / Doubtfully / No
Measured: Follow up at day 15
Number of infectious events related to polyp trap
Was the event related to the polyptrap? Yes / Probably / Doubtfully / No
Measured: Follow up at day 15
Secondary outcomes (1)
Number of inconsistent anatomopathological results
Was the anatomopathological finding consistent with the findings in the endoscopy?
Measured: Follow up at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross InfectionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 3,238 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Consorci Sanitari de Terrassa, Hospital Clinic of Barcelona, Hospital Universitario La Fe, Hospital Sant Bernabé de Berga, Hospital Dos de Maig, Hospital Universitari Joan XXIII de Tarragona., Centro Medico Teknon, Clínica Mi Tres Torres Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838312
- Sponsor's protocol ID
- IIBSP-RPT-2024-69
- Acronym
- POLYPTRAP
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reuse of Polyp Traps, a Way to Approach Sustainability: A Multicentric Non-inferiority Study
- ClinicalTrials.gov ID
- NCT06838312
- Acronym / sponsor ID
- POLYPTRAP / IIBSP-RPT-2024-69
- Conditions
- Cross Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,238 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Consorci Sanitari de Terrassa, Hospital Clinic of Barcelona, Hospital Universitario La Fe, Hospital Sant Bernabé de Berga, Hospital Dos de Maig, Hospital Universitari Joan XXIII de Tarragona., Centro Medico Teknon, Clínica Mi Tres Torres Barcelona
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 20 Feb 2025 (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 environmental impact of healthcare practice in the context of climate change is in the spotlight. Digestive endoscopy units are the third hospital unit that generates the most waste and environmental impact. For this reason, scientific societies advice studying and adopting more sustainable clinical practices, reconsidering current protocols for reprocessing and disinfection of single-use material. One of the devices, widely used and which generates a large amount of waste, is the polyp trap. It allows an easy recovery of the polyps removed during endoscopy. This device is discarded after a single use in some centers, and reused after washing and disinfection in others. Manufacturers recommend the single-use of the device, even there is no scientific evidence to support this action. In the investigators endoscopy unit, 3800 polyp traps are used yearly. The investigators hypothesis is that reusing the polyp catcher has similar safety to disposal after a single use, with better environmental and economic results. Objectives: To evaluate the safety of the reused and discarded after a single-use polyp trap. The investigators will assess 1) the post-colonoscopy infection rate and 2) the reliability of the anatomopathological study, 3) CO2 emissions and 4) costs of each practice. Methodology: A non-inferiority study will be carried out by observing the usual clinical practice of different centers and collecting data that suggest infection, cross-sampling and general complications. The results will be easily applicable in endoscopy units and will serve as a basis for future studies with other more controversial devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reuse Group | – | Other: Reuse or dispose a polyp trappatients from centres that routinely reuse polyp traps. |
| Single Use Group | – | Other: Reuse or dispose a polyp trappatients from centres that dispose polyp traps after a single use. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients who have undergone a colonoscopy in which a polyp trap was used.
Key inclusion criteria (2 listed)
- All patients who undergo an elective colonoscopy will be recruited for the study.
Key exclusion criteria (2 listed)
- Patients who complete the colonoscopy without a polypectomy.
- Patients who complete the colonoscopy without the use of a polyp trap.
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 |
|---|---|---|
| Reuse or dispose a polyp trapParticipant hospitals will be separated into two groups, according to their standard clinical practice: A) reuse or B) dispose polyp traps after a colonoscopy with polypectomy. Centres will participate with their current method of using polyp traps. Work dynamics will not change as patients will be recruited from centers that routinely reuse or dispose polyp traps. | Other | Reuse Group, Single Use Group |
Primary outcome
Number of patients with symptoms suggesting infection
Time frame: Follow up at day 15
Did the patient present any of the following symptoms or diagnosis after the endoscopy? * Fever * Bacteraemia * Bronchoaspiration / Pneumonia * Other: Comments: * None
Number of infectious events related to endoscopy
Time frame: Follow up at day 15
Was the event related to the endoscopy procedure? Yes / Probably / Doubtfully / No
Number of infectious events related to polyp trap
Time frame: Follow up at day 15
Was the event related to the polyptrap? Yes / Probably / Doubtfully / No
1 secondary outcome
Number of inconsistent anatomopathological results
Time frame: Follow up at day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Cross Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruitingObservational study
Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
Cross Infection, Intensive Care Units
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross Infection, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 2 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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliva Ros Fargas, nurse (+34 608 879 422, oros@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with symptoms suggesting infection (time frame: Follow up at day 15). The study lists 3 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 20 Feb 2025.