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

Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00737425

Enrollment

Registered

2008-08-19

Start date

2008-09-30

Completion date

Unknown

Last updated

2008-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Keywords

laparoscopic-assisted surgery, abdominal, pain relief, wound healing, low intensity ultrasound

Brief summary

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.

Interventions

DEVICEPainShield

DEVICESham PainShield

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Pain and discomfort will be measured using appropriate validated questionnaires.	Pain assessment will be performed daily

Secondary

Measure	Time frame
Infections will be assessed by concomitant antibiotic intake	Concomitant medications will be assessed daily

Countries

Israel

Contacts

Primary ContactPetachia Reissman, MD

+972 2 6666310

Backup ContactEran Lavi, MD