Pancreatitis, ChronicNCT04672642
Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations
A study testing SpyGlass DS in people with Pancreatitis, Chronic, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Pancreatitis, Chronic
- What is being tested?
- SpyGlass DS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2021to 13 Mar 2024
- Phase
- Interventional
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 18 and over;
- with chronic calcifying pancreatitis;
- having already received endoscopic treatment for pancreatic pain related to stenosis and / or pancreatic stones;
- having given free, informed and written consent;
- being affiliated to a social security scheme or beneficiary of such a scheme.
Who cannot join
- contraindications to performing an upper digestive endoscopy;
- haemorrhagic disease, haemostasis and coagulation disorder (PR <60%, PTT> 40 s and platelets <60,000 / mm3;
- pregnant or breastfeeding woman;
- adult patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
- person subject to a safeguard measure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the SpyGlass DS vs Standard Method for Detection of Residual Pancreatic Calculations After Endoscopic Treatment
The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.
- Conditions
- Pancreatitis, Chronic
- Being tested
- SpyGlass DS
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpyGlass DSDevice
Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)
| Study group | Role | What they receive |
|---|---|---|
| SpyGlass DS after endoscopic treatment | Experimental | Not described Receives: Device: SpyGlass DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual pancreatic stones detected by the Spyglass DS
rate of residual pancreatic stones detected by the SpyGlass DS, after a treatment by CT-scan and ERCP (recommended standard method) showing no stones in the Wirsung's duct. .
Measured: baseline
Secondary outcomes (9)
Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)
rate of residual pancreatic stones extracted by by the SpyGlass DS accessory (the SpyGlass Basket) after being detected by the SpyGlass DS.
Measured: baseline
VAS score for pancreatic pain
pain visual analogue scale from 0 (no pain) to 10 (worst pain possible)
Measured: preoperative, 1 month, 6 months and 12 months
Analgesic consumption
level of analgesic (if several analgesics of different levels are used, the analgesic of the highest level will be taken into account each time)
Measured: preoperative, 1 month, 6 months and 12 months
Analgesic consumption
total daily dose (mg)
Measured: preoperative, 1 month, 6 months and 12 months
Rate of patients hospitalized for pancreatic pain
Measured: 12 months
Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain
Measured: 12 months
Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)
Measured: 12 months
Self-administered quality of life questionnaire score
36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: preoperative, 1 month, 6 months and 12 months
AE rate and type
Measured: during and immediately after the operation, 7 days, 1 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start12 Jul 2021
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672642
- Sponsor's protocol ID
- SPY PCC 2020
- Status last verified
- Jul 2021
- First submitted
- 11 Dec 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SpyGlass DS vs Standard Method for Detection of Residual Pancreatic Calculations After Endoscopic Treatment
- ClinicalTrials.gov ID
- NCT04672642
- Acronym / sponsor ID
- SPY PCC 2020
- Conditions
- Pancreatitis, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 17 Dec 2020 (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 purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpyGlass DS after endoscopic treatment | Experimental | Device: SpyGlass DS |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 and over;
- with chronic calcifying pancreatitis;
- having already received endoscopic treatment for pancreatic pain related to stenosis and / or pancreatic stones;
- having given free, informed and written consent;
- being affiliated to a social security scheme or beneficiary of such a scheme.
Key exclusion criteria (5 listed)
- contraindications to performing an upper digestive endoscopy;
- haemorrhagic disease, haemostasis and coagulation disorder (PR <60%, PTT> 40 s and platelets <60,000 / mm3;
- pregnant or breastfeeding woman;
- adult patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
- person subject to a safeguard measure.
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 |
|---|---|---|
| SpyGlass DSDetection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP) | Device | SpyGlass DS after endoscopic treatment |
Primary outcome
Residual pancreatic stones detected by the Spyglass DS
Time frame: baseline
rate of residual pancreatic stones detected by the SpyGlass DS, after a treatment by CT-scan and ERCP (recommended standard method) showing no stones in the Wirsung's duct. .
9 secondary outcomes
Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)
Time frame: baseline
VAS score for pancreatic pain
Time frame: preoperative, 1 month, 6 months and 12 months
Analgesic consumption
Time frame: preoperative, 1 month, 6 months and 12 months
Analgesic consumption
Time frame: preoperative, 1 month, 6 months and 12 months
Rate of patients hospitalized for pancreatic pain
Time frame: 12 months
Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain
Time frame: 12 months
Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)
Time frame: 12 months
Self-administered quality of life questionnaire score
Time frame: preoperative, 1 month, 6 months and 12 months
AE rate and type
Time frame: during and immediately after the operation, 7 days, 1 month, 6 months and 12 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 19 Sep 2024.
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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?
A study testing SpyGlass DS in people with Pancreatitis, Chronic, run by Hospital St. Joseph, Marseille, France 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 5 inclusion and 5 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 19 Sep 2024. 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?
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?
Residual pancreatic stones detected by the Spyglass DS (time frame: baseline). 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 19 Sep 2024.