|By Marketwired .||
|September 5, 2013 06:17 PM EDT||
HOUSTON, TX -- (Marketwired) -- 09/05/13 -- Dr. Aldona J. Spiegel at the Center for Breast Restoration in Houston, Texas is enrolling mastectomy patients into a clinical study designed to evaluate a new tissue expansion method for those who choose to undergo breast reconstruction. Dr. Spiegel is the first in Texas to offer this randomized, controlled clinical study to directly compare the outcomes of the traditional saline tissue expansion method to an investigational, remote-controlled, needle-free, carbon dioxide-based tissue expansion system known as The AeroForm Patient Controlled Tissue Expander System.
Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a standard saline or silicone breast implant can be placed.
"Traditionally, women undergoing breast reconstruction have had to undergo a long process of inconvenient injections using conventional saline expanders to create a pocket for a standard implant following a mastectomy," said Dr. Spiegel, breast reconstruction surgeon. "This investigational system eliminates the need for saline injections by allowing the patient to trigger the release of small amounts of compressed carbon-dioxide through the valve of a tiny chamber located inside the expander."
The patient uses the remote control to gradually inflate the investigational expander in small, pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits.
Patients in the study will be randomly selected to receive the investigational expander or a traditional saline expander. The patients who receive the investigational expander will use a wireless remote control to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander. Once the patient's tissue is adequately expanded, the expander is removed and a standard implant placed during a surgical procedure.
A clinical study in Australia showed the average expansion time associated with the remote-controlled tissue expander was 17 days, a fraction of the time required using traditional expanders which can take months to achieve full expansion.
The current standard of care in tissue expansion involves implanting a saline expander under the skin and pectoral muscle following a mastectomy procedure. The patient returns to her doctor weekly for bolus saline injections which can take as long as four to five months.
Dr. Aldona Spiegel and other Reconstructive Surgeons at hospitals across the U.S. are participating in the study. Enrollment will continue until a total of 92 AeroForm expanders and 46 saline expanders have been implanted in patients. AeroForm will be evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a standard breast implant. Secondary measurements will include the average number of days needed to achieve the desired expansion, total reconstruction time, pain and patient satisfaction.
The AeroForm Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, CA. The U.S. Food and Drug Administration (FDA) has granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study and it has been approved for enrollment.
For more information on the study, please visit clinicaltrials.gov (NCT01425268).
If you or someone you know is interested in joining the study in Houston, please call Dr. Spiegel's office at 713-441-6102.
E-mail: [email protected]
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, will provide a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services ...
Mar. 26, 2017 06:45 PM EDT Reads: 4,231
SYS-CON Events announced today that Ocean9will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
Mar. 26, 2017 06:30 PM EDT Reads: 2,026
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, will posit that disruption is inevitable for c...
Mar. 26, 2017 05:00 PM EDT Reads: 2,094
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Mar. 26, 2017 05:00 PM EDT Reads: 3,569
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Mar. 26, 2017 03:30 PM EDT Reads: 6,512
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Mar. 26, 2017 03:15 PM EDT Reads: 2,787
DevOps has often been described in terms of CAMS: Culture, Automation, Measuring, Sharing. While we’ve seen a lot of focus on the “A” and even on the “M”, there are very few examples of why the “C" is equally important in the DevOps equation. In her session at @DevOps Summit, Lori MacVittie, of F5 Networks, explored HTTP/1 and HTTP/2 along with Microservices to illustrate why a collaborative culture between Dev, Ops, and the Network is critical to ensuring success.
Mar. 26, 2017 03:00 PM EDT Reads: 10,529
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Mar. 26, 2017 02:45 PM EDT Reads: 933
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Mar. 26, 2017 02:30 PM EDT Reads: 1,735
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great dea...
Mar. 26, 2017 02:15 PM EDT Reads: 4,356
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
Mar. 26, 2017 02:00 PM EDT Reads: 3,375
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Mar. 26, 2017 01:45 PM EDT Reads: 1,820
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Mar. 26, 2017 01:45 PM EDT Reads: 8,498
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Mar. 26, 2017 01:15 PM EDT Reads: 2,112
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
Mar. 26, 2017 01:15 PM EDT Reads: 3,555