Pancreatic DiseasesARCHIMEDESNCT03767166
The Archimedes Biodegradable Biliary and Pancreatic Stents
An observational study of Pancreatic Diseases, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Diseases
- What is being tested?
- Biodegradable biliary and pancreatic stents placement
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 31 Dec 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
Who may be able to join
- Patients with an indication to position one ore more biliary plastic stents during ERCP
- Patients with an indication to position a pancreatic plastic stent during ERCP
Who cannot join
- Age < 18 y
- Life expectancy < 1 m,
- Inability to pass a guidewire through stricture
- Contra-indication for endoscopy or interventional radiology
- Presence of partial gastric resection
- Unsigned informing consent form, ICF
- Pregnancy
- Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.
The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.
- Conditions
- Pancreatic Diseases
- Being tested
- Biodegradable biliary and pancreatic stents placement
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable biliary and pancreatic stents placementDevice
Biodegradable biliary and pancreatic stents placement
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodegradation time
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767166
- Sponsor's protocol ID
- 2275
- Acronym
- ARCHIMEDES
- Status last verified
- Mar 2021
- First submitted
- 20 Nov 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderloni A, Fugazza A, Maroni L, Ormando V, Maselli R, Carrara S, Cappello A, Mangiavillano B, Omodei P, Preatoni P, Galtieri PA, Pellegatta G, Repici A. New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video). Gastrointest Endosc. 2020 Aug;92(2):405-411. doi: 10.1016/j.gie.2020.02.049. Epub 2020 Mar 5.
PubMed 32145287
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
- ClinicalTrials.gov ID
- NCT03767166
- Acronym / sponsor ID
- ARCHIMEDES / 2275
- Conditions
- Pancreatic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Dec 2018 (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.
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.
The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
Key inclusion criteria (2 listed)
- Patients with an indication to position one ore more biliary plastic stents during ERCP
- Patients with an indication to position a pancreatic plastic stent during ERCP
Key exclusion criteria (8 listed)
- Age < 18 y
- Life expectancy < 1 m,
- Inability to pass a guidewire through stricture
- Contra-indication for endoscopy or interventional radiology
- Presence of partial gastric resection
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 |
|---|---|---|
| Biodegradable biliary and pancreatic stents placementBiodegradable biliary and pancreatic stents placement | Device | – |
Primary outcome
Biodegradation time
Time frame: 24 Months
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 18 Mar 2021.
- Derived from this study: PubMed 32145287Anderloni A, Fugazza A, Maroni L, Ormando V, Maselli R, Carrara S, Cappello A, Mangiavillano B, Omodei P, Preatoni P, Galtieri PA, Pellegatta G, Repici A. New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video). Gastrointest Endosc. 2020 Aug;92(2):405-411. doi: 10.1016/j.gie.2020.02.049. Epub 2020 Mar 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Diseases, run by Istituto Clinico Humanitas 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 2 inclusion and 8 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 18 Mar 2021. 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?
Biodegradation time (time frame: 24 Months). 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 NCT03767166, which also lists 1 linked publication.
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 Mar 2021.