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

Shaare Zedek Medical Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Wounds

Interventions

PainShieldDEVICE

Sham PainShieldDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

Outcomes

Primary Outcomes

Pain and discomfort will be measured using appropriate validated questionnaires.

Time frame: Pain assessment will be performed daily

Secondary Outcomes

Infections will be assessed by concomitant antibiotic intake

Time frame: Concomitant medications will be assessed daily

Central Contacts

Petachia Reissman, MD

CONTACT

+972 2 6666310

Eran Lavi, MD

CONTACT

+972 2 6666310

Data from ClinicalTrials.gov

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