Breaking News
March 25, 2019 - Benefits of osteoporosis treatment in postmenopausal women outweigh the perceived risks
March 25, 2019 - Researchers find evidence of Cryptosporidium parasite in Minnesota’s public water systems
March 25, 2019 - Three Clues to Raised Risk of Miscarriage
March 25, 2019 - Structured play helps toddlers self-regulate, altering their life course
March 25, 2019 - Translating horror into justice: Stanford psychiatrist advocates for human rights
March 25, 2019 - HORIBA Medical introduces D-Dimer reagent for Yumizen G hemostasis range
March 25, 2019 - Recurrent pregnancy loss may be caused by sperm DNA damage, finds study
March 25, 2019 - Special Collection tracks development of new diagnostic tests for tuberculosis
March 25, 2019 - Air Force develops genetic test to predict mental performance
March 25, 2019 - To abort or not to abort—making difficult choices alone
March 25, 2019 - Computer vision technology could aid ICU care by spotting movement
March 25, 2019 - IONTAS wins ‘Small Business of the Year’ category at Cambridge News Business Excellence Awards 2019
March 25, 2019 - First postpartum depression drug gets FDA nod
March 25, 2019 - Research Recognition Award will help improve lives of young people with absence epilepsy
March 25, 2019 - Bisphosphonates to treat osteoporosis appears to be beneficial for all women
March 25, 2019 - Dolomite Bio releases new Drop-seq datasets for single-cell RNA sequencing
March 25, 2019 - Hemoglobin A1c blood test may underestimate prevalence of diabetes
March 25, 2019 - Eating leafy green vegetables may help maintain muscle strength and mobility
March 25, 2019 - BMA secures state-backed clinical negligence indemnity scheme for GP trainees
March 25, 2019 - Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant
March 25, 2019 - Adding breakfast to classrooms may have a health downside
March 25, 2019 - She Was Dancing On The Roof And Talking Gibberish. A Special Kind Of ER Helped Her.
March 25, 2019 - KNAUER introduces new Sepapure FPLC columns and media for protein purification tasks
March 25, 2019 - Weight loss in obese migraine sufferers can improve their quality of life
March 25, 2019 - Exposure to particulate air pollution may lead to reduced sperm production
March 25, 2019 - Synthetic peptide appears to disrupt inflammation and protect kidneys from nephritis
March 25, 2019 - New guideline focuses on strategies to improve health of older adults with diabetes
March 25, 2019 - Study evaluates prescribing of preventive drugs at the end of life in older adults with cancer
March 25, 2019 - Radial or femoral approaches for PCI are equal in terms of survival in heart attack patients
March 25, 2019 - Study shows how some autoimmune diseases are more closely related than others
March 25, 2019 - Long term opioid medications impacts production of important hormones
March 25, 2019 - FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
March 25, 2019 - CDC researchers report on trends in hospital breastfeeding policies
March 25, 2019 - States Push For Caregiver Tax Credits
March 25, 2019 - Females on ketogenic diet fail to show metabolic benefits in animal model
March 25, 2019 - Modulating stiffness of blood-forming stem cells could facilitate mobilization procedures
March 25, 2019 - Gene editing regulations to be tightened
March 25, 2019 - CPAP treatment can result in weight loss in people with sleep apnea and obseity
March 25, 2019 - Highly attractive businesswomen are considered less trustworthy ‘femmes fatales’
March 25, 2019 - Breast Density Categorization Varies With Screening Modality
March 25, 2019 - Researchers explore link between metal exposure and Parkinson’s symptoms
March 25, 2019 - Later meal timing may contribute to weight gain
March 25, 2019 - Around one in hundred people has autism spectrum condition in China
March 25, 2019 - Research paves way for new standard of care to improve heart’s pump function
March 25, 2019 - Exposure to HIV virus, antiretroviral therapy before birth linked to obesity and asthma-like symptoms
March 25, 2019 - Transgender men preserve their fertility potential after one year of testosterone therapy
March 25, 2019 - Tighter Blood Pressure Control May Prevent Brain Lesions
March 25, 2019 - A reward now or later? Exploring impulsivity in Parkinson’s disease patients
March 25, 2019 - Financial incentives fail to increase completion rates of colorectal cancer screening tests mailed to patients
March 25, 2019 - New research program launched to highlight sexual harassment in academia
March 25, 2019 - Hemoglobin A1c blood test does not detect diabetes in most patients, shows study
March 25, 2019 - Wyss Technology licensed by Sherlock Biosciences to create affordable molecular diagnostics
March 25, 2019 - DWK Life Sciences launches KIMBLE GLS 80 Media Bottle and Multiport Cap System
March 25, 2019 - New study aims to reduce online sexual exploitation of children
March 25, 2019 - Want healthier eating habits? Start with a workout
March 25, 2019 - New approach to prescribing antibiotics could curb resistance
March 24, 2019 - Theravance Biopharma Announces First Patient Dosed in Phase 2b/3 Study of TD-1473 in Patients with Ulcerative Colitis
March 24, 2019 - Prenatal DHA prevents blood-pressure increase from obesity during childhood
March 24, 2019 - Combined immunosuppression may be effective, safe in treating older patients with Crohn’s disease
March 24, 2019 - GSK sells health drinks arm, buys US cancer treatment firm
March 24, 2019 - Bacteria and innate immune factors in birth canal, cervix may be key to predicting preterm births
March 24, 2019 - IgG antibodies play unexpected role in atherosclerosis
March 24, 2019 - Sounds and vibrations are quite similar for the brain, finds new study
March 24, 2019 - Practices for Reducing COPD Hospital Readmissions Explored
March 24, 2019 - Could an eye doctor diagnose Alzheimer’s before you have symptoms?
March 24, 2019 - Enzyme inhibitor stops inflammation and neurodevelopmental disorders in mouse models
March 24, 2019 - Walk, Dance, Clean: Even a Little Activity Helps You Live Longer
March 24, 2019 - Americans used less eye care in 2014 versus 2008
March 24, 2019 - Study finds link between depression in 20s linked to memory loss in 50s
March 24, 2019 - New tool helps physiotherapy students to master complex fine motor skills
March 24, 2019 - The AMR Centre secures £2.3m funding boost
March 24, 2019 - Study examines effects of taking ondansetron during first trimester of pregnancy
March 24, 2019 - Researchers identify a more effective treatment for cancer
March 24, 2019 - Open-source solution for multiparametric optical mapping of the heart’s electrical activity
March 24, 2019 - New nanotechnology approach shows promise in treating triple negative breast cancer
March 24, 2019 - Trevena Announces Publication of APOLLO-1 Results in The Journal of Pain Research Highlighting Oliceridine’s Potential for Management of Moderate-to-Severe Acute Pain
March 24, 2019 - Maternal deaths following C-section 50 times higher in Africa compared to high-income countries
March 24, 2019 - Apple watch could detect irregular heart beat says study
March 24, 2019 - Queen Mary University of London’s BCI boosts radionuclide imaging capabilities with MILabs VECTor technology
March 24, 2019 - Girls should be encouraged to gain more ball skills, shows study
AEGEA Medical begins PACE II clinical study in women who underwent endometrial ablation

AEGEA Medical begins PACE II clinical study in women who underwent endometrial ablation

image_pdfDownload PDFimage_print

AEGEA Medical, Inc. has announced the commencement of the Post-Ablation Cavity Access (PACE II) clinical study in women who previously underwent endometrial ablation as part of AEGEA’s pivotal trial of the company’s patented Adaptive Vapor Ablation technology. The multi-center observational study, which is being conducted at seven sites across the U.S. in up to 50 women, is designed to assess uterine cavity access as well as the feasibility of diagnostic and therapeutic interventions three to four years following treatment.

AEGEA Medical is conducting the PACE II study based on results from the AEGEA PACE pilot study, which found that post-procedure access to the mid-uterine cavity or beyond was possible in 82 percent of the study’s 11 patients who previously participated in a Phase II study of vapor ablation in The Netherlands. The primary observational endpoint of PACE II is the ability to access the uterine cavity and perform a diagnostic hysteroscopic exam, with other observational endpoints including feasibility of endometrial biopsy and IUD placement, the ability to visualize the uterine cornua/ostia, and presence and characteristics of adhesions within the uterine cavity. The company expects PACE II to be completed within six months.

“While endometrial ablation technologies have served physicians and their patients well for some time, the issue of post-procedure uterine cavity access has never really been addressed,” said Maria Sainz, president and CEO of AEGEA Medical. “We believe this is a very important success metric for the therapy, as it speaks to the possibility of future uterine-related interventions. The PACE Pilot data on 11 patients treated with Adaptive Vapor Ablation technology is very promising in how Vapor Ablation can address this unmet need, preserving physician and patient options in the future.”

Endometrial ablation is a safe, effective and fast-growing procedure for the treatment of heavy menstrual bleeding (menorrhagia), with the number of U.S. cases estimated to have increased from 430,000 in 2014 to 490,000 in 2017 alone. As the number of procedures continues to rise per year, studies have shown that scar tissue and re-access to the cavity can be challenging post therapy, limiting the ability to search for suspected cancer via ultrasound or biopsy, and ruling out the use of IUDs for therapeutic intervention. In these scenarios, the lack of post-procedure uterine cavity access often leaves women with hysterectomy as the only viable option.

“Post-procedure uterine cavity access is the next big topic in endometrial ablation,” said the study’s National Principal Investigator, Alan Johns, MD, Medical Director, Clinical Research Baylor Research Institute, Fort Worth. “Given the early performance of AEGEA’s Adaptive Vapor Ablation technology in this area, I believe it has the potential to address this issue, providing physicians and patients with a more thoughtful approach to endometrial ablation that allows for future uterine interventions as necessary. Importantly, this multi-center study has been designed with objective criteria to avoid patient selection bias. Additionally, the study includes independent expert review of the hysteroscopy imagery to further increase the data’s scientific rigor.”

Tagged with:

About author

Related Articles