Partial NephrectomyNCT05106218
Assessment of the SurroundScope in Urologic Surgical Procedures
A study testing SurroundScope and Standard Laparoscope in people with Partial Nephrectomy and Nephrectomy, run by 270Surgical at 1 site in Israel.
Trial summary
The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Nephrectomy, Nephrectomy, Laparoscopy
- What is being tested?
- SurroundScope and Standard Laparoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age greater than or equal to 18
- Capable of giving informed consent.
- Scheduled for laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy
Who cannot join
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- Patients with contraindications to undergo laparoscopic surgery.
- Patients with American Society of Anesthesiology (ASA) class* >3
- Advanced cirrhosis with failure of hepatic function
- Patients who have participated in another interventional clinical study in the last month.
- Pregnancy
- Unable to consent (due to cultural, language or neurological barriers)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petah Tikva, 49100
Andrew Nado, MD, +972 (0)547228500, nadua@clalit.org.il
About this study
The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope
Read the detailed description
The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope. 270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will compare the use of the 270Surgical system (The "SurroundScope") to standard laparoscope during partial nephrectomy and nephrectomy urological surgeries;
- Conditions
- Partial Nephrectomy, Nephrectomy, Laparoscopy
- Being tested
- SurroundScope, Standard Laparoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurroundScopeDevice
Also called 270System
The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.
Standard LaparoscopeDevice
The procedure will be performed according to the institution's standard of care, using the Standard laparoscope for visualization.
| Study group | Role | What they receive |
|---|---|---|
| SurroundScope | Experimental | For laparoscopic camera system, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used Receives: Device: SurroundScope |
| Standard laparoscope | Active comparator | For laparoscopic camera system, the Standard laparoscope that is in a standard use at the medical center is used Receives: Device: Standard Laparoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery
Data collected include - skin to skin time of surgery
Measured: During the surgery - Since the first incision performed till the last incision is closed
Analysis of the efficient work time with the standard scope and the SurroundScope - tools and ports Visibility time
Data collected include - Visibility time of tools and ports in the Field of view
Measured: During the surgery - Since the first incision performed till the last incision is closed
Analysis of the efficient work time with the standard scope and the SurroundScope - time of scope removals
Data collected include - Time of scope removals during the case to clear smoke or fog
Measured: During the surgery - Since the first incision performed till the last incision is closed
Secondary outcomes (3)
Time of defined surgical tasks - port placement time
Time to complete port placement will be measured
Measured: During the defined surgical task
Time of defined surgical tasks - transection time
Time to transection of renal artery \& Vein with stapler will be measured
Measured: During the defined surgical task
Time of defined surgical tasks - clamp time
Clamp time during partial nephrectomy will be measured
Measured: During the defined surgical task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startMar 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial NephrectomyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For laparoscopic camera system to be used in urological surgeries, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used. This will be compared to the standard laparoscopic system use. The study will evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope. The procedure will be performed according to the institution's standard of care, using the SurroundScope or the standard scope for visualization. Each surgery will be captured on video.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 270Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Nado, MD, Principal investigator, Rabin Medical Center, 39 Jabotinski St., Petah Tikva 49100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106218
- Sponsor's protocol ID
- CL 466
- Status last verified
- Nov 2021
- First submitted
- 7 Oct 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the SurroundScope in Urologic Surgical Procedures
- ClinicalTrials.gov ID
- NCT05106218
- Acronym / sponsor ID
- CL 466
- Conditions
- Partial Nephrectomy, Nephrectomy, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- 270SurgicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Nov 2021 (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.
The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope
Detailed description
The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope. 270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will compare the use of the 270Surgical system (The "SurroundScope") to standard laparoscope during partial nephrectomy and nephrectomy urological surgeries;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- For laparoscopic camera system to be used in urological surgeries, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used. This will be compared to the standard laparoscopic system use. The study will evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope. The procedure will be performed according to the institution's standard of care, using the SurroundScope or the standard scope for visualization. Each surgery will be captured on video.
| Arm | Type | Receives |
|---|---|---|
| SurroundScope | Experimental | Device: SurroundScopeFor laparoscopic camera system, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used |
| Standard laparoscope | Active comparator | Device: Standard LaparoscopeFor laparoscopic camera system, the Standard laparoscope that is in a standard use at the medical center is used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18
- Capable of giving informed consent.
- Scheduled for laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy
Key exclusion criteria (7 listed)
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- Patients with contraindications to undergo laparoscopic surgery.
- Patients with American Society of Anesthesiology (ASA) class* >3
- Advanced cirrhosis with failure of hepatic function
- Patients who have participated in another interventional clinical study in the last month.
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 |
|---|---|---|
| SurroundScopeAlso: 270SystemThe procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization. | Device | SurroundScope |
| Standard LaparoscopeThe procedure will be performed according to the institution's standard of care, using the Standard laparoscope for visualization. | Device | Standard laparoscope |
Primary outcome
Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery
Time frame: During the surgery - Since the first incision performed till the last incision is closed
Data collected include - skin to skin time of surgery
Analysis of the efficient work time with the standard scope and the SurroundScope - tools and ports Visibility time
Time frame: During the surgery - Since the first incision performed till the last incision is closed
Data collected include - Visibility time of tools and ports in the Field of view
Analysis of the efficient work time with the standard scope and the SurroundScope - time of scope removals
Time frame: During the surgery - Since the first incision performed till the last incision is closed
Data collected include - Time of scope removals during the case to clear smoke or fog
3 secondary outcomes
Time of defined surgical tasks - port placement time
Time frame: During the defined surgical task
Time of defined surgical tasks - transection time
Time frame: During the defined surgical task
Time of defined surgical tasks - clamp time
Time frame: During the defined surgical task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andrew Nado, MD principal investigator
Rabin Medical Center, 39 Jabotinski St., Petah Tikva 49100
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurroundScope and Standard Laparoscope in people with Partial Nephrectomy and Nephrectomy, run by 270Surgical at 1 site in Israel.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Feb 2022. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Nado, MD (+972 (0)547228500, nadua@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery (time frame: During the surgery - Since the first incision performed till the last incision is closed). The study lists 3 primary outcomes in all. 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 9 Feb 2022.