General Laparoscopic Surgeries Clinical Trial
Official title:
Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
| Verified date | September 2017 |
| Source | M.S.T. Medical Surgery Technology LTD. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | February 2018 |
| Est. primary completion date | February 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Aged = 18 years 2. Able to provide a written informed consent Exclusion Criteria: 1. Pregnancy 2. Obesity (BMI >35 Kg/m2) 3. Contra-indications for performing laparoscopy |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Meander Medisch Centrum | Amersfoort |
| Lead Sponsor | Collaborator |
|---|---|
| M.S.T. Medical Surgery Technology LTD. |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success rate in performing an operation with at least one OR person less | During surgery | ||
| Secondary | Duration of the operation | During surgery | ||
| Secondary | Number of times the laparoscope is removed for cleaning | During surgery | ||
| Secondary | Usability evaluation | Up to two days post surgery |