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Looking at Safety and Feasibility of Novel Laparoscopic Device (LapSpace)

NCT03210636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-07-07

No results posted yet for this study

Summary

In order to help the surgeons to clearly visualize their target operating area and create an optimal operative field throughout the procedure, the device owners have developed a new class of inflatable laparoscopic retractors for both bowel and organ specific retraction with load bearing bore by an inflatable reinforced material that is atraumatic, biocompatible, and are self-retained, i.e. require no personnel to maintain them post-placement.

Specifically, the device owners menu of designs hold a range of 50 - 100 % of the bowels and support at minimum 6 lbs in the vertical direction. All the device owners devices enter the abdominal cavity through a conventional 10mm incision. The pressure within the inflatable tubes of the device will not be above 15 mmHg, which is the current pressure used to insufflate the patient's abdomen with carbon dioxide (CO2). The devices are able to retract up to 10 cm of the bowels in any direction within the coronal plane and retract the bowels 10cm upward, towards the abdominal wall. Finally, the invention here-in described can be manipulated easily to provide retraction of specific organs, including, liver, bladder, uterus, etc.

The device has been approved by the FDA for clinical use (FDA Registered) and the purpose of this study is to evaluate the device in laparoscopic operations for safety and feasibility.

Conditions

  • Patients Undergoing Laparoscopic Surgery

Interventions

DEVICE

LapSpace

use of atraumatic laparoscopic retractor for patients undergoing laparoscopic surgery

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-01-31
Completion
2016-01-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210636 on ClinicalTrials.gov