A Prospective Post-Market Study of the BARD Angiomed Ureteral Stents

A Prospective Post-Market Study of the BARD Angiomed Ureteral Stents - EVERGREEN I

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00019193

Enrollment

225

Registered

2020-03-09

Start date

2020-05-07

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Urologic diseases

Interventions

Group 1: Subjects will be adult patients undergoing urologic interventions suffering from urologic diseases that require either temporary or permanent use of a ureteral stent supporting urinary draina

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The subject has urologic disease that requires treatment with a ureteral stent, and BARD Angiomed Ureteral Stent(s) can be utilized for treatment according to its labelled intended purpose. 2. The subject provides written informed consent. 3. The subject is = 18 years old.

Exclusion criteria

Exclusion criteria: 4. The subject is unable or unwilling to provide written informed consent. 5. The subject has an untreated urinary tract infection.

Design outcomes

Primary

Measure	Time frame
Composite of unplanned hospitalization and/or re-intervention due to complications of the device or index procedure prior to the end of the pre-planned ureteral stent indwelling period, if related to the urologic disease treated during the index-procedure, as determined by the Investigator. Re-intervention is defined as any inpatient or outpatient treatment for a device- or procedure-related adverse event that meets the definition of an SAE.	—

Measure

Time frame

Composite of unplanned hospitalization and/or re-intervention due to complications of the device or index procedure prior to the end of the pre-planned ureteral stent indwelling period, if related to the urologic disease treated during the index-procedure, as determined by the Investigator. Re-intervention is defined as any inpatient or outpatient treatment for a device- or procedure-related adverse event that meets the definition of an SAE.

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Secondary

Measure	Time frame
Complications defined as the observation of any device- and procedure-related adverse event related to usage of the study device, as determined by the Investigator. Trackability defined as successful insertion and navigation to the intended anatomic location of the study device, as determined by the Investigator. Visibility defined as acceptable fluoroscopic displaying of the study device, as determined by the Investigator. Compatibility defined as ability to use the study device with ancillary devices, as determined by the Investigator. Replacement defined as successful removal or exchange of the study device from the intended anatomic location, as determined by the Investigator.	—

Measure

Time frame

Complications defined as the observation of any device- and procedure-related adverse event related to usage of the study device, as determined by the Investigator. Trackability defined as successful insertion and navigation to the intended anatomic location of the study device, as determined by the Investigator. Visibility defined as acceptable fluoroscopic displaying of the study device, as determined by the Investigator. Compatibility defined as ability to use the study device with ancillary devices, as determined by the Investigator. Replacement defined as successful removal or exchange of the study device from the intended anatomic location, as determined by the Investigator.

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Countries

Germany

Contacts

Public ContactRalph Oberneder

Urologie Planegg

info@ukmp.de+49 (0)89 85693 - 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026