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Anastomotic Perfusion Measuring Device, a Pilot Trial

Anastomotic Perfusion Measuring Device, a Pilot Trial - APM Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56669
Enrollment
12
Registered
2023-08-02
Start date
2026-02-06
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic leakage

Interventions

&nbsp
APM device&nbsp

Sponsors

Maastricht Universitair Medisch Centrum +
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria:  -Oral and written informed consent (IC) -Age 18 years and older -Elective colorectal surgery 

Exclusion criteria

Exclusion criteria:  -No informed consent -Palliative surgery -Emergency surgery -Mental handicap 

Design outcomes

Primary

MeasureTime frame
1. Time needed to measure bowel-brachial index 2. Percentage of successful bowel-brachial index measurements, the percentage needs to be 90% or higher. The APM device needs to display and index and not display an error message. It will be allowed to try multiple times per patient. 3. Safety of the product will be defined as that no adverse events related to the APM measurement are observed.

Secondary

MeasureTime frame
/

Countries

Netherlands

Contacts

Public ContactMJJR Crombag

Maastricht Universitair Medisch Centrum +

julie.crombag@mumc.nl0629652220

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026