Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations

NCT04672642 | Completed

• 1 other identifier: SPY PCC 2020
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• 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. .

  baseline

Secondary Outcomes (9)

• Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)

  baseline

• VAS score for pancreatic pain

  preoperative, 1 month, 6 months and 12 months

• Analgesic consumption

  preoperative, 1 month, 6 months and 12 months

• Analgesic consumption

  preoperative, 1 month, 6 months and 12 months

• Rate of patients hospitalized for pancreatic pain

  12 months

Study Arms (1)

SpyGlass DS after endoscopic treatment

EXPERIMENTAL

Device: SpyGlass DS

Interventions

SpyGlass DS DEVICE

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

SpyGlass DS after endoscopic treatment

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hopital Saint Jospeh Marseille

Marseille, France

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: July 12, 2021
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: September 19, 2024

Record last verified: 2021-07

Locations

FR (1)