Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

NCT ID: NCT04672642

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2024-03-13

Brief Summary

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The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.

Detailed Description

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Conditions

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Pancreatitis, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SpyGlass DS after endoscopic treatment

Group Type EXPERIMENTAL

SpyGlass DS

Intervention Type DEVICE

Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)

Interventions

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SpyGlass DS

Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Saint Jospeh Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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SPY PCC 2020

Identifier Type: -

Identifier Source: org_study_id

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