AdrenalectomyNCT07813247
Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging
A study testing indocyanine green imaging in people with Adrenalectomy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is a prospective randomized study comparing robotic adrenalectomy with versus without intraoperative indocyanine green imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenalectomy
- What is being tested?
- indocyanine green imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients scheduled for robotic adrenalectomy
Who cannot join
- patients scheduled for laparoscopic or open adrenalectomy or with an iodine allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Chaise Brewer, 216-672-2131, brewerc3@ccf.org
Eren Berber
About this study
Official title: Randomized Prospective Study of Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging
This is a prospective randomized study comparing robotic adrenalectomy with versus without intraoperative indocyanine green imaging.
Read the detailed description
Identification of the adrenal gland intraoperatively is critical to get in to the correct surgical plane and perform minimally invasive adrenalectomy with clear margins and without causing excessive bleeding. Intraoperative ultrasound has been used traditionally, but suffers from air artefact when there is insufficient contact between the tissue and the ultrasound probe. Furthermore, intraoperative ultrasound requires interruption of the procedure for the ultrasound, prolonging operative time and may not be possible when the dissection plane deepens. Indocyanine green (ICG) fluorescence has emerged over the past few years as a new intraoperative imaging modality. As ICG fluorescence is directly related to the perfusion of tissues and the adrenal gland has one of the highest blood supplies among organs in the abdomen, the adrenalectomy is a perfect application of this technology. Our group, as well as others, have described the safety and feasibility of ICG fluorescence imaging during robotic adrenalectomy over the last decade, however, whether the use of this imaging creates an impact of robotic adrenalectomy on intraoperative and perioperative outcomes is unknown, as no randomized study has been done on this topic.
It is unknown if intraoperative ICG imaging improves outcomes compared to conventional adrenalectomy that does not use this imaging. Based on our retrospective experience, ICG-guided adrenalectomy may facilitate dissection part of the procedure and hence shorten operative time by providing a road map regarding the dissection planes in different steps of the operation. So, the hypothesis of the study is that ICG imaging may shorten the dissection step of minimally invasive adrenalectomy.
- Conditions
- Adrenalectomy
- Being tested
- indocyanine green imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine green imagingProcedure or surgery
intraoperative use of indocyanine green imaging during robotic adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| adrenalectomy with indocyanine green imaging | Active comparator | robotic adrenalectomy with intraoperative indocyanine green imaging Receives: Procedure: indocyanine green imaging |
| conventional adrenalectomy | No intervention | conventional robotic adrenalectomy without intraoperative indocyanine green imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
dissection time
duration of time for adrenal dissection in robotic adrenalectomy
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start31 Jul 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdrenalectomyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaise Brewer, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813247
- Sponsor's protocol ID
- 26-702
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study of Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT07813247
- Acronym / sponsor ID
- 26-702
- Conditions
- Adrenalectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized study comparing robotic adrenalectomy with versus without intraoperative indocyanine green imaging.
Detailed description
Identification of the adrenal gland intraoperatively is critical to get in to the correct surgical plane and perform minimally invasive adrenalectomy with clear margins and without causing excessive bleeding. Intraoperative ultrasound has been used traditionally, but suffers from air artefact when there is insufficient contact between the tissue and the ultrasound probe. Furthermore, intraoperative ultrasound requires interruption of the procedure for the ultrasound, prolonging operative time and may not be possible when the dissection plane deepens. Indocyanine green (ICG) fluorescence has emerged over the past few years as a new intraoperative imaging modality. As ICG fluorescence is directly related to the perfusion of tissues and the adrenal gland has one of the highest blood supplies among organs in the abdomen, the adrenalectomy is a perfect application of this technology. Our group, as well as others, have described the safety and feasibility of ICG fluorescence imaging during robotic adrenalectomy over the last decade, however, whether the use of this imaging creates an impact of robotic adrenalectomy on intraoperative and perioperative outcomes is unknown, as no randomized study has been done on this topic.
It is unknown if intraoperative ICG imaging improves outcomes compared to conventional adrenalectomy that does not use this imaging. Based on our retrospective experience, ICG-guided adrenalectomy may facilitate dissection part of the procedure and hence shorten operative time by providing a road map regarding the dissection planes in different steps of the operation. So, the hypothesis of the study is that ICG imaging may shorten the dissection step of minimally invasive adrenalectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adrenalectomy with indocyanine green imaging | Active comparator | Procedure: indocyanine green imagingrobotic adrenalectomy with intraoperative indocyanine green imaging |
| conventional adrenalectomy | No intervention | –conventional robotic adrenalectomy without intraoperative indocyanine green imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients scheduled for robotic adrenalectomy
Key exclusion criteria (1 listed)
- patients scheduled for laparoscopic or open adrenalectomy or with an iodine allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indocyanine green imagingintraoperative use of indocyanine green imaging during robotic adrenalectomy | Procedure or surgery | adrenalectomy with indocyanine green imaging |
Primary outcome
dissection time
Time frame: intraoperative
duration of time for adrenal dissection in robotic adrenalectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indocyanine green imaging in people with Adrenalectomy, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dissection time (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.