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

NCT03210636 | Completed DMC FDA Device

• 1 other identifier: IRB00035940
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Surgeon preference

  surgeon questionnaire given to measure preference using a rating of 1 to 5 with 1 being "would not use to 5 being "I would use"

  immediately following surgery, up to 2 hours

Study Arms (1)

With Use of LapSpace

EXPERIMENTAL

evaluate ease of use, safety evaluations, surgeon and clinician feedback

Device: LapSpace

Interventions

LapSpace DEVICE

use of atraumatic laparoscopic retractor for patients undergoing laparoscopic surgery

With Use of LapSpace

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consenting adults between the ages of 18 to 65
• patients undergoing laparoscopic operations
• english-speaking patients
• patients who are capable of consenting for their own operation
• non-emergent, elective cases

You may not qualify if:

• non-laparoscopic cases
• emergent cases
• no witnessed consent
• children and elderly adults age \>65
• non-english speaking patients

Sponsors & Collaborators

• Johns Hopkins University: lead
• LapSpace Medical: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: July 7, 2017
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 7, 2017

Record last verified: 2017-07