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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05106218
Other study ID # CL 466
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2022
Est. completion date December 2022

Study information

Verified date November 2021
Source 270Surgical
Contact Andrew Nado, MD
Phone +972 (0)547228500
Email nadua@clalit.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope


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;


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age greater than or equal to 18 - Capable of giving informed consent. - Scheduled for laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SurroundScope
The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.
Standard Laparoscope
The procedure will be performed according to the institution's standard of care, using the Standard laparoscope for visualization.

Locations

Country Name City State
Israel Rabin Medical Center Petah Tikva

Sponsors (1)

Lead Sponsor Collaborator
270Surgical

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events Amount of intraoperative adverse event During the surgery - Since the first incision performed till the last incision is closed
Other Length of stay Length of stay at the hospital following the surgery in days Since the surgery completion to discharge from the medical center
Other Surgeon's perception 270surgical Surgeon's perception of the 270surgical System - 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). Immediately following the surgery is completed
Primary 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 During the surgery - Since the first incision performed till the last incision is closed
Primary 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 During the surgery - Since the first incision performed till the last incision is closed
Primary 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 During the surgery - Since the first incision performed till the last incision is closed
Secondary Time of defined surgical tasks - port placement time Time to complete port placement will be measured During the defined surgical task
Secondary Time of defined surgical tasks - transection time Time to transection of renal artery & Vein with stapler will be measured During the defined surgical task
Secondary Time of defined surgical tasks - clamp time Clamp time during partial nephrectomy will be measured During the defined surgical task
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