WoundsPhase 4NCT00737425
Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
A Phase 4 study testing PainShield in people with Wounds, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- PainShield
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Petachia Reissman, MD contact
Eran Lavi, MD contact
About this study
Official title: Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery
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.
- Conditions
- Wounds
- Being tested
- PainShield, Sham PainShield
- Keywords
- laparoscopic-assisted surgery, abdominal, pain relief, wound healing, low intensity ultrasound
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainShieldDevice
Sham PainShieldDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: PainShield |
| 2 | Sham comparator | Not described Receives: Device: Sham PainShield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and discomfort will be measured using appropriate validated questionnaires.
Measured: Pain assessment will be performed daily
Secondary outcomes (1)
Infections will be assessed by concomitant antibiotic intake
Measured: Concomitant medications will be assessed daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nanovibronix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737425
- Sponsor's protocol ID
- NV-PS-02-001
- Status last verified
- Oct 2008
- First submitted
- 17 Aug 2008
- Last updated
- 28 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00737425
- Acronym / sponsor ID
- NV-PS-02-001
- Conditions
- Wounds
- Keywords
- laparoscopic-assisted surgery, abdominal, pain relief, wound healing, low intensity ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Nanovibronix
- Study start
- Sep 2008
- First posted
- 19 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: PainShield |
| 2 | Sham comparator | Device: Sham PainShield |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainShield | Device | 1 |
| Sham PainShield | Device | 2 |
Primary outcome
Pain and discomfort will be measured using appropriate validated questionnaires.
Time frame: Pain assessment will be performed daily
1 secondary outcome
Infections will be assessed by concomitant antibiotic intake
Time frame: Concomitant medications will be assessed daily
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petachia Reissman, MD contact
Eran Lavi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PainShield in people with Wounds, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petachia Reissman, MD (+972 2 6666310), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and discomfort will be measured using appropriate validated questionnaires. (time frame: Pain assessment will be performed daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2008.