NCT05960149

Brief Summary

Imaging of the vascular nerve bundle using Indocyanine Green

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2023

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

May 31, 2023

Last Update Submit

July 21, 2023

Conditions

Prostate Cancer AdenocarcinomaErectile Dysfunction Following Radical Prostatectomy

Keywords

erectile dysfunction and indocyanine greenradical prostatectomy and indocyanine green

Outcome Measures

Primary Outcomes (2)

  • Evaluation of erectile function.

    Evaluation of erectile function after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.Evaluation of surgical margin positivity after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green. Both groups will evaluate their erectile function by completing the preoperative International Index of Erectile Function Every groups of participants will fill the International Index of Erectile Function -5 again after surgery in 3. -6. -9. -12 months. The possible scores for the International Index of Erectile Function- 5 range from 0 to 30, and Erectile disfonction is classified into five categories based on the scores: severe (0-10), moderate (11-16), mild to moderate (17-21), mild (22-25), and no erectile disfonction (26-30).

    up to 12 months

  • Evaluation of surgical margin positivity

    Postoperative surgical margin positivity will be compared in both groups according to the results of the postoperative pathology report. Surgical margin positivity in both groups will be evaluated as a percentage and it will be evaluated whether there is a significant difference between the two groups

    Up to 12 months

Study Arms (2)

Group using Indocyanine Green

EXPERIMENTAL

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

Drug: using Indocyanine Green

The Indocyanine Green -unused group

EXPERIMENTAL

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

Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomy

Interventions

using Indocyanine GreenDRUG

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

Also known as: IV Indocyanine Green injection
Group using Indocyanine Green
Nerve-sparing robot-assisted laparoscopic radical prostatectomyPROCEDURE

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

The Indocyanine Green -unused group

Eligibility Criteria

AgeUp to 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with low-intermediate risk prostate cancer

You may not qualify if:

  • Patients high risk prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Araz Musaev

    Ankara Universitry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Araz Musaev, Dr

CONTACT

+905364536276msyv.araz@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvesitgator

Study Record Dates

First Submitted

May 31, 2023

First Posted

July 25, 2023

Study Start

July 30, 2023

Primary Completion

December 3, 2025

Study Completion

March 31, 2026

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share