Patients Indicated for Periampullary or Pancreaticobiliary ExaminationPhase 1NCT03685903
Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
A Phase 1 study testing CapsoCam® Plus (SV-3) capsule endoscope in people with Patients Indicated for Periampullary or Pancreaticobiliary Examination, run by Capso Vision, Inc. at 1 site in United States.
Trial summary
This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Indicated for Periampullary or Pancreaticobiliary Examination
- What is being tested?
- CapsoCam® Plus (SV-3) capsule endoscope
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2018to 15 Sep 2020
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females at least 18 years of age.
- Provided written HIPAA Informed Consent in the IRB approved language.
- Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.
Who cannot join
- Patients with existing biliary stent will be excluded
- EUS/ERCP exclusion criteria: per medical practice, including:
- Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
- Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
- Capsule Endoscopy (CE) exclusion criteria:
- CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy.
- Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.
- Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology
This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.
- Being tested
- CapsoCam® Plus (SV-3) capsule endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsoCam® Plus (SV-3) capsule endoscopeDevice
Endoscope Capsule
| Study group | Role | What they receive |
|---|---|---|
| CapsoCam® Plus (SV-3) capsule endoscope | Experimental | Endoscope Capsule Receives: Device: CapsoCam® Plus (SV-3) capsule endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to detect and visualize the duodenal papilla
Rate of duodenal papilla detection
Measured: during capsule endoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start26 Sep 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Indicated for Periampullary or Pancreaticobiliary ExaminationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capso Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685903
- Sponsor's protocol ID
- CLN-CVI-4801
- Status last verified
- May 2020
- First submitted
- 24 Sep 2018
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology
- ClinicalTrials.gov ID
- NCT03685903
- Acronym / sponsor ID
- CLN-CVI-4801
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Capso Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 26 Sep 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 observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CapsoCam® Plus (SV-3) capsule endoscope | Experimental | Device: CapsoCam® Plus (SV-3) capsule endoscopeEndoscope Capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females at least 18 years of age.
- Provided written HIPAA Informed Consent in the IRB approved language.
- Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.
Key exclusion criteria (8 listed)
- Patients with existing biliary stent will be excluded
- EUS/ERCP exclusion criteria: per medical practice, including:
- Capsule Endoscopy (CE) exclusion criteria:
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 |
|---|---|---|
| CapsoCam® Plus (SV-3) capsule endoscopeEndoscope Capsule | Device | CapsoCam® Plus (SV-3) capsule endoscope |
Primary outcome
The ability to detect and visualize the duodenal papilla
Time frame: during capsule endoscopy procedure
Rate of duodenal papilla detection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No
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?
A Phase 1 study testing CapsoCam® Plus (SV-3) capsule endoscope in people with Patients Indicated for Periampullary or Pancreaticobiliary Examination, run by Capso Vision, Inc. at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The ability to detect and visualize the duodenal papilla (time frame: during capsule endoscopy procedure). 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 29 May 2020.