ERCPRADIO-ERGONCT07691580
Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography
A study testing CAPTIV system in people with ERCP and Biomechanic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
A number of best practice recommendations have been developed to improve practitioner comfort, similar to those recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a chair during the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERCP, Biomechanic, Musculoskeletal Disorders
- What is being tested?
- CAPTIV system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2026to Jul 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subject (age ≥ 18 years)
- hepato-gastroenterologist
- Performing ERCP
- Person who has given consent for participation in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, 80000
Clara Yzet, MD, 03 22 08 88 50, yzet.clara@chu-amiens.fr
Henri Thiebault, MD
About this study
A number of best practice recommendations have been developed to improve practitioner comfort, similar to those recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a chair during the procedure. The use of lead aprons is essential for certain endoscopic procedures (ERCP drainage of the bile ducts, prosthesis placement, etc.). Several retrospective studies in the surgical and radiological fields have shown an increased risk of MSDs among these populations. To distribute the weight of the apron, several shapes are available to limit stress. An apron weighs approximately 7 kg, due in particular to the amount of lead. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during ERCP.
- Conditions
- ERCP, Biomechanic, Musculoskeletal Disorders
- Being tested
- CAPTIV system
- Keywords
- musculoskeletal disorders, ERCP, biomechanic, physiology
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPTIV systemDevice
Each practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored.
| Study group | Role | What they receive |
|---|---|---|
| CAPTIV system | Experimental | • Each practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored. Receives: Device: CAPTIV system |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of average muscle during ERCP
measurement of average muscle during ERCP
Measured: 1 day
measurement of angular analysis during ERCP
Measured: day 1
Secondary outcomes (1)
level of stress during the practice of ERCP
level of stress during the practice of ERCP by analyzing the average data obtained from cardiofrequency monitoring
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start8 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France, University Hospital, Caen, Clinique de l'Europe, Amiens, Hôpital Privé Saint-Claude, Saint Quentin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691580
- Sponsor's protocol ID
- PI2026_843_0024
- Acronym
- RADIO-ERGO
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 10 Jul 2026
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT07691580
- Acronym / sponsor ID
- RADIO-ERGO / PI2026_843_0024
- Conditions
- ERCP, Biomechanic, Musculoskeletal Disorders
- Keywords
- musculoskeletal disorders, ERCP, biomechanic, physiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France, University Hospital, Caen, Clinique de l'Europe, Amiens, Hôpital Privé Saint-Claude, Saint Quentin
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jul 2026 (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.
A number of best practice recommendations have been developed to improve practitioner comfort, similar to those recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a chair during the procedure. The use of lead aprons is essential for certain endoscopic procedures (ERCP drainage of the bile ducts, prosthesis placement, etc.). Several retrospective studies in the surgical and radiological fields have shown an increased risk of MSDs among these populations. To distribute the weight of the apron, several shapes are available to limit stress. An apron weighs approximately 7 kg, due in particular to the amount of lead. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during ERCP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAPTIV system | Experimental | Device: CAPTIV system• Each practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subject (age ≥ 18 years)
- hepato-gastroenterologist
- Performing ERCP
- Person who has given consent for participation in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CAPTIV systemEach practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored. | Device | CAPTIV system |
Primary outcome
measurement of average muscle during ERCP
Time frame: 1 day
measurement of average muscle during ERCP
measurement of angular analysis during ERCP
Time frame: day 1
1 secondary outcome
level of stress during the practice of ERCP
Time frame: day 1
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 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for ERCP
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
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Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
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Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
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Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPTIV system in people with ERCP and Biomechanic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 4 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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 France. 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?
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 Clara YZET, DR (33+3 22 08 88 50, yzet.clara@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of average muscle during ERCP (time frame: 1 day). The study lists 2 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 10 Jul 2026.