Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT01929902
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2013-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Laparoscopic Aquamantys Device in General Surgery: A Prospective Observational Study to Evaluate the Efficacy and Accuracy
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.
Detailed Description:
The primary objective of this study is to assess the efficacy of placement and accuracy of the Aquamantys device in 20 patients that require general surgery. High frequency electrosurgery is the application of frequency in the range of 300 kHz up to several MHz in order to coagulate or destroy tissue. Due to technological advancements, knowledge of how frequency and other physical modes interact with biological materials has become increasingly important in order for the surgeon to provide a safe and consistent surgery. The Aquamantys system utilizes radiofrequency energy and saline irrigation for cutting tissue and stopping excessive bleeding.
The Aquamantys system features the following:
1. Cone-shaped electrodes designed to aid blunt dissection;
2. Large bipolar electrode configuration allowing for hemostatic sealing across broad planes of tissue;
3. Bipolar electrodes alleviate the need for grounding pad;
4. Transcollation technology allows for controlled depth of energy penetration.
During surgery, the Aquamantys device will be utilized in order to stop excessive bleeding and to cut vessels. The patient will be monitored by the surgeon and research nurse coordinator before surgery, intra-operatively and post-operatively until discharge from the hospital. The study participant will follow-up post-operatively with the surgeon per standard of care.
The Aquamantys system features the following:
1. Cone-shaped electrodes designed to aid blunt dissection;
2. Large bipolar electrode configuration allowing for hemostatic sealing across broad planes of tissue;
3. Bipolar electrodes alleviate the need for grounding pad;
4. Transcollation technology allows for controlled depth of energy penetration.
During surgery, the Aquamantys device will be utilized in order to stop excessive bleeding and to cut vessels. The patient will be monitored by the surgeon and research nurse coordinator before surgery, intra-operatively and post-operatively until discharge from the hospital. The study participant will follow-up post-operatively with the surgeon per standard of care.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: