An interventional study of The FemTouch delivery system and Gynomunal gel treatment in Vaginal Atrophy Patients With GSM, sponsored by Lumenis Be Ltd.. Recruiting at 1 site in Germany. Open to female participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment
Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment.
GSM-related symptoms significantly decrease the quality of life of post-menopausal women and harm the quality of life of up to seventy-five percent of breast cancer survivors who suffer from one or more GSM symptoms. Although varieties of hormonal and non-hormonal treatment options are available for post-menopausal women, the level of compliance is variable. One of the main reasons is the discomfort associated with the use of these measures, and in case of hormonal therapies certain risks and side effects. For cancer survivors, the possibility of having hormonal treatment must be considered against the possibility of increasing the risk of reoccurrence.
Therefore, women afflicted with GSM, whether it is age-related GSM or post-cancer GSM, are in need of additional therapeutic alternatives. Recently, supportive evidence is being gathered, showing that laser treatments to vaginal mucosa for GSM related symptoms are safe and effective. A prospective randomized comparative study comparing non-hormonal gel treatment to fractional CO2 vaginal laser treatment will contribute to optimizing treatment in this patient population
Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology. The system enables the delivery of laser energy along the vaginal walls. Through the use of the scanner, this laser energy is delivered in a fractional manner, selectively treating less than 100% of the tissue surface. This allows the tissue to heal much faster than when treating non-fractionally (100% of the surface) because much of the tissue is left unharmed, while the efficacy of the treatment remains significant.
Device: The FemTouch delivery system
Gynomunal is a hormone/free, vaginal moisturizing gel for women with vaginal dryness. Gynomunal has been clinically proven in treating vaginal dryness, and its symptoms, including itching, burning, and pain (as well as discomfort during sex). Gynomunal is a liposomal formulation containing natural hop extract, Vitamin E and hyaluronic acid.
Drug: Gynomunal gel treatment
The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology
hormone/free, vaginal moisturizing gel for women with vaginal dryness
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
Efficacy will be determined by an improvement from baseline to post-treatment in the score of the Vaginal Assessment Scale (VAS), mean of 4 items scored 0-3; 0=none 3=severe; higher score = worse condition.
Time frame: Through study completion, an average of 1 year
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
Efficacy of fractionated CO2 laser treatments will be determined by treatment completion rates (i.e. the number of women that complete the treatment regimen out of the randomized subjects).
Time frame: Through study completion, an average of 1 year
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment.
Efficacy of fractionated CO2 laser treatments will be determined by Subject Downtime evaluation.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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