Use of Indocyanine Green in Robotic Prostate Surgeries

NCT ID: NCT05960149

Last Updated: 2023-07-25

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

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2026-03-31

Brief Summary

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Imaging of the vascular nerve bundle using Indocyanine Green

Detailed Description

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Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green

Conditions

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Prostate Cancer Adenocarcinoma Erectile Dysfunction Following Radical Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group using Indocyanine Green

Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green

Group Type EXPERIMENTAL

using Indocyanine Green

Intervention Type DRUG

Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green

The Indocyanine Green -unused group

Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green

Group Type EXPERIMENTAL

Nerve-sparing robot-assisted laparoscopic radical prostatectomy

Intervention Type PROCEDURE

Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green

Interventions

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using Indocyanine Green

Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green

Intervention Type DRUG

Nerve-sparing robot-assisted laparoscopic radical prostatectomy

Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green

Intervention Type PROCEDURE

Other Intervention Names

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IV Indocyanine Green injection

Eligibility Criteria

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Inclusion Criteria

* Patients with low-intermediate risk prostate cancer

Exclusion Criteria

* Patients high risk prostate cancer
Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Araz Musaev

Principal İnvesitgator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Araz Musaev

Role: PRINCIPAL_INVESTIGATOR

Ankara Universitry

Central Contacts

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Araz Musaev, Dr

Role: CONTACT

+905364536276

Other Identifiers

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A01062021Z

Identifier Type: -

Identifier Source: org_study_id

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