Intraoperative Pancreatic Leakage Indicator – Post Market Confirmatory Study (PMCF, IDEAL Stage I)

Phase 1

• Conditions: K86; Other diseases of pancreas

• Registration Number: DRKS00027559
• Lead Sponsor: Magle Chemoswed AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Study Completion: 2023-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Planned partial pancreatectomy for any indication including minimally invasive and open distal pancreatectomy and partial pancreatoduodenectomy
2. Age = 18 years
3. Ability of subject to understand character and individual consequences of the clinical trial.
4. Willing and able to give written informed consent for participation in the investigation

Exclusion Criteria

1. American Society of Anesthesiologists (ASA) Score > 3
2. Pregnancy or lactation
3. Allergy or known intolerability to bromothymol blue or potato starch
4. Participation in another interventional trial with interference of intervention or outcome of this study
5. Any condition which could result in an undue risk for the patient in the opinion of the investigator
6. Expected lack of compliance or language problems

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this post market clinical follow-up trial is to confirm the usability as well as the safety of the indicator application in the clinical environment of elective pancreatic resection when used according to the instructions for use.