Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy

NCT ID: NCT02345603

Last Updated: 2019-04-24

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-12-31

Brief Summary

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Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.

Detailed Description

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Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During the surgery the renal arteries at both sides are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Renal arterial blood flow is checked by Doppler after the freezing procedure, during the surgery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in 24h ambulatory blood pressure levels and of course safety parameters such as creatinine levels.

Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryo-therapy

Cryo-therapy of renal arteries

Group Type EXPERIMENTAL

Cryo-therapy

Intervention Type PROCEDURE

Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery

Control

No intervention in renal arteries

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cryo-therapy

Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* planned prophylactic surgery for abdominal aortic aneurysm

Exclusion Criteria

* hypotension,
* inability to understand study protocol
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Fredrik H Nystrom

MD PhD professor Head of internal medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Linkoping

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2014/45-31

Identifier Type: -

Identifier Source: org_study_id

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