An interventional study of SurroundScope in Laparoscopic Surgery, sponsored by 270Surgical. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by 270Surgical · Not applicable, Interventional, and Treatment
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.
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".
270Surgical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was used
Device: SurroundScope
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.
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).
Time frame: Day of surgery
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.
Time frame: 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.
Time frame: Day of surgery
A record of complications related to the SurroundScope
The SurroundScope related operative complications, that require further clinical intervention
Time frame: Day of surgery up to 2 weeks after the surgical procedure
Additional measurements - timing, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital.
Measuring time of laparoscopic procedure (lap inserted to final lap removal)
Time frame: day of surgery
Additional measurements- Intraoperative events
Measurements include collecting a log of events that could have been missed with standard scope and were captured in the side screens
Time frame: day of surgery
Additional measurements - lengs of stay, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital.
Number of days patients stayed at the hospital following the operation
Time frame: Up to two weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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