AbdominoplastyPhase 4ACENCT01175889
Megadyne Ace Incision/Dissection Study
A Phase 4 study testing E-Z Clean ACE Blade in people with Abdominoplasty and Bilateral Breast Reduction, run by Megadyne Medical Products Inc. at 3 sites in United States.
Trial summary
The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdominoplasty, Bilateral Breast Reduction, Bilateral Breast Lift
- What is being tested?
- E-Z Clean ACE Blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Dec 2012
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is >18 years of age or < 60 years old
- Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof
- Subject is able to discontinue anticoagulant therapy (including Aspirin)
- Subject is willing and able to comply with study follow-up procedures
- Subject is willing to provide written informed consent for their participation in the study
Who cannot join
- Subject has a history of smoking in the last 6 months prior to surgery.
- Subject has a history of type I or type II Diabetes.
- Subject has an active infection of any kind at the time of enrollment
- Subject has a known coagulopathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Southwest Surgical Suites, LLC
Fort Wayne, Indiana, 46804
Center for Plastic Surgery
Twin Falls, Idaho, 83301
Plastic and Reconstructive Surgery University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Megadyne ACE Incision/Dissection Study
The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
- Conditions
- Abdominoplasty, Bilateral Breast Reduction, Bilateral Breast Lift, Bilateral Brachioplasty, Bilateral Lateral Thigh and Buttocks Lift
- Being tested
- E-Z Clean ACE Blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Z Clean ACE BladeDevice
Also called ACE Blade
The prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
| Study group | Role | What they receive |
|---|---|---|
| one side ACE blade | Experimental | Not described Receives: Device: E-Z Clean ACE Blade |
| one side scalpel | Active comparator | Not described Receives: Device: E-Z Clean ACE Blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Wound Healing/Scar Formation
Primary Effectiveness Objective Evaluate wound healing/ scar formation between incisions made using a cold steel scalpel and incisions made using the ACE Blade per photographic evidence at 120 days by an independent observer
Measured: 120 Days
Secondary outcomes (1)
Evaluate patient satisfaction relating to wound healing
Secondary Effectiveness Objective Evaluate patient satisfaction relating to wound healing/ scar formation between incisions made using a cold steel scalpel and incisions made using the ACE Blade at 120 days
Measured: 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Megadyne Medical Products Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan D Lewis, M.D., Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175889
- Sponsor's protocol ID
- ACE MS 1
- Acronym
- ACE
- Status last verified
- Oct 2012
- First submitted
- 3 Aug 2010
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megadyne ACE Incision/Dissection Study
- ClinicalTrials.gov ID
- NCT01175889
- Acronym / sponsor ID
- ACE / ACE MS 1
- Conditions
- Abdominoplasty, Bilateral Breast Reduction, Bilateral Breast Lift, Bilateral Brachioplasty, Bilateral Lateral Thigh and Buttocks Lift
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Megadyne Medical Products Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Aug 2010 (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 Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one side ACE blade | Experimental | Device: E-Z Clean ACE Blade |
| one side scalpel | Active comparator | Device: E-Z Clean ACE Blade |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is >18 years of age or < 60 years old
- Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof
- Subject is able to discontinue anticoagulant therapy (including Aspirin)
- Subject is willing and able to comply with study follow-up procedures
- Subject is willing to provide written informed consent for their participation in the study
Key exclusion criteria (4 listed)
- Subject has a history of smoking in the last 6 months prior to surgery.
- Subject has a history of type I or type II Diabetes.
- Subject has an active infection of any kind at the time of enrollment
- Subject has a known coagulopathy
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 |
|---|---|---|
| E-Z Clean ACE BladeAlso: ACE BladeThe prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof. | Device | one side ACE blade, one side scalpel |
Primary outcome
Evaluate Wound Healing/Scar Formation
Time frame: 120 Days
Primary Effectiveness Objective Evaluate wound healing/ scar formation between incisions made using a cold steel scalpel and incisions made using the ACE Blade per photographic evidence at 120 days by an independent observer
1 secondary outcome
Evaluate patient satisfaction relating to wound healing
Time frame: 120 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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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.
Ryan D Lewis, M.D. study chair
Sponsor GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing E-Z Clean ACE Blade in people with Abdominoplasty and Bilateral Breast Reduction, run by Megadyne Medical Products Inc. at 3 sites in United States.
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 5 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 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Wound Healing/Scar Formation (time frame: 120 Days). 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 25 Oct 2012.