Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 4

Conditions: Wounds

Treatments: Device: PainShield; Device: Sham PainShield

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00737425

NV-PS-02-001

Details and patient eligibility

About

The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject's Age ≥ 18
• Subject is able, agrees and signs the Informed Consent Form
• Subject requires laparoscopic-assisted abdominal surgery
• Incision size following the laparoscopy between 4-7 cm

Exclusion criteria

• Epidural analgesia
• IV PCA
• Subject has any condition, which precludes compliance with study and/or device instructions
• Subject is currently participating in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

1

Active Comparator group

Treatment:

Device: PainShield

2

Sham Comparator group

Treatment:

Device: Sham PainShield