Laparoscopic SurgeryNCT04651270
Assessment of the Wide Field of View Provided by the SurroundScope
A study testing SurroundScope in people with Laparoscopic Surgery, run by 270Surgical at 1 site in Israel.
Trial summary
The aim of this study is to assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- SurroundScope
- 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
- 9 Dec 2020to 30 Dec 2023
- 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 general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System
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 surgery
- Patients with 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, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 31048
Gideon Sroka, MD, +972 (4) -8359137, Gideon.sroka@b-zion.org.il
About this study
The aim of this study is to assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery.
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 evaluate standard laparoscopic surgery using the 270Surgical system; "The SurroundScope".
- Conditions
- Laparoscopic Surgery
- Being tested
- SurroundScope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurroundScopeDevice
The study will evaluate standard laparoscopic surgery using the 270Surgical system. The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.
| Study group | Role | What they receive |
|---|---|---|
| SurroundScope | Experimental | For laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was used Receives: Device: SurroundScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the need and potential benefits of the wide field of view
Assessed by a multi-question subjective questionnaire completed in the OR, immediately after the case, by the surgeon and the camera person and constructed on a Likert-type, 5-point scale (1=Strongly disagree, 2=Disagree, 3=Neither agree or disagree, 4=Agree, 5=Strongly agree).
Measured: Day of surgery
Secondary outcomes (3)
Assessment of the 270 Lenses clearance contribution to the procedure.
Lenses clearance contribution will be assessed by:
Rating of the visual impairment due to smoke using a likert-type scale of 1-5: 1=imperceptible, 2= perceptible but not interfering, 3=same as in standard procedure, 4=annoying, 5=Very annoying.
Measured: Day of surgery
Assessment of the 270 Lenses clearance contribution to the procedure.
Lenses clearance contribution will be assessed by:
Amount of removals and pauses for fog and smoke incidences using a scale of 1-5: 1=none, 2= less than in standard procedure, 3=same as in standard procedure, 4= more than in standard procedure, 5=much more than in standard procedure.
Measured: Day of surgery
A record of complications related to the SurroundScope
The SurroundScope related operative complications, that require further clinical intervention
Measured: Day of surgery up to 2 weeks after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start9 Dec 2020
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 270Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gideon Sroka, MD, Principal investigator, Bnai Zion Medical Center, 47 Golomb St. Haifa, 31048, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651270
- Sponsor's protocol ID
- CL 0334
- Status last verified
- Apr 2023
- First submitted
- 17 Nov 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Wide Field of View Provided by the SurroundScope
- ClinicalTrials.gov ID
- NCT04651270
- Acronym / sponsor ID
- CL 0334
- Conditions
- Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- 270SurgicalIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 3 Dec 2020 (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 assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery.
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 evaluate standard laparoscopic surgery using the 270Surgical system; "The SurroundScope".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SurroundScope | Experimental | Device: SurroundScopeFor laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was 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 general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System
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 surgery
- Patients with 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 |
|---|---|---|
| SurroundScopeThe study will evaluate standard laparoscopic surgery using the 270Surgical system. The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization. | Device | SurroundScope |
Primary outcome
Assessment of the need and potential benefits of the wide field of view
Time frame: Day of surgery
Assessed by a multi-question subjective questionnaire completed in the OR, immediately after the case, by the surgeon and the camera person and constructed on a Likert-type, 5-point scale (1=Strongly disagree, 2=Disagree, 3=Neither agree or disagree, 4=Agree, 5=Strongly agree).
3 secondary outcomes
Assessment of the 270 Lenses clearance contribution to the procedure.
Time frame: Day of surgery
Assessment of the 270 Lenses clearance contribution to the procedure.
Time frame: Day of surgery
A record of complications related to the SurroundScope
Time frame: Day of surgery up to 2 weeks after the surgical procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
Gideon Sroka, MD principal investigator
Bnai Zion Medical Center, 47 Golomb St. Haifa, 31048, Israel
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 in people with Laparoscopic Surgery, 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 14 Apr 2023. 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 Gideon Sroka, MD (+97248359137 ext. 0, Gideon.sroka@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the need and potential benefits of the wide field of view (time frame: Day of surgery). 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 14 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.