Clinical trial NCT04651270: Assessment of the Wide Field of View Provided by the SurroundScope
Official title: Assessment of the Wide Field of View Provided by the SurroundScope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Surgery
Lead sponsor: 270Surgical
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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".

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18
2. Capable of giving informed consent
3. Scheduled for general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System

Exclusion Criteria:

1. Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
2. Patients with contraindications to undergo surgery
3. Patients with ASA class\* \>3
4. Advanced cirrhosis with failure of hepatic function
5. Patients who have participated in another interventional clinical study in the last month
6. Pregnancy
7. Unable to consent (due to cultural, language or neurological barriers)

Primary outcomes:
measure: Assessment of the need and potential benefits of the wide field of view
timeFrame: Day of surgery
Secondary outcomes:
measure: Assessment of the 270 Lenses clearance contribution to the procedure.
timeFrame: Day of surgery
measure: Assessment of the 270 Lenses clearance contribution to the procedure.
timeFrame: Day of surgery
measure: A record of complications related to the SurroundScope
timeFrame: Day of surgery up to 2 weeks after the surgical procedure
Other outcomes:
measure: Additional measurements - timing, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital.
timeFrame: day of surgery
measure: Additional measurements- Intraoperative events
timeFrame: day of surgery
measure: Additional measurements - lengs of stay, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital.
timeFrame: Up to two weeks
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center, 47 Golomb St. Haifa, 31048, Israel
name: Gideon Sroka, MD
role: PRINCIPAL_INVESTIGATOR
References: