CTRI/2023/09/057513尚未招募4 期
An Open labelled, Multicentre, Single Arm, clinical investigation in Indian population toevaluate the Safety and Efficacy of Los Deline TM (Sterile Hydrophilic, volumizing, injectable Gelimplant) for Endoprosthesis (contour & volume correction) of Human Soft Tissues. - NI
JCP International Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •01. Age 18.00 Years to 60.00 Years (inclusive both).
- •02. Willing to sign the informed consent form and willingness to undergo plastic minimally invasive surgeries (contouring).
- •03. Subjects for whom any of the below are indicated in the opinion of the Investigators:
- •a. Primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: Subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis and aplasia.
- •b. A subject who is seeking primary buttock augmentation indicated for the following: Subject dissatisfaction with size or shape of buttock.
- •c. A subject who is seeking breast or buttocks soft tissues reconstruction or revision-augmentation or revision-reconstruction.
- •d. Primary need for:
- •i. Mammary dysplasia
- •ii. Post-surgical breast deformity
- •iii. Hypotrphic buttocks
- •e. Secondary need for:
- •i. Breast ptosis 1 – 2 degree
- •ii. Breast asymmetry
- •iii. Buttocks ptosis 1 – 2 degree
- •iv. Buttocks asymmetry
- •v. Local trunk soft tissue dystrophy
- •04. A subject who is ready to abstain from other face, breast, buttocks and lower legs soft tissues plastic surgical or cosmetic procedures during the study period.
- •05. Non-pregnant, non-breast feeding females and must agree to abstain from breast feeding for more than 06 months after completion of study duration.
- •06. A Female subject of childbearing potential who agree to use medically acceptable contraception (hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam, intrauterine device and condom, diaphragm with condom, or condom with spermicidal.) during the trial. Alternatively, they may declare that they are abstaining from sexual intercourse, are surgically sterile (vasectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal (menstruation ceased for 12 consecutive months prior to signing of the informed consent form).
- •07. A subject must be in good health (a person should not have any autoimmune diseases, acute inflammatory disease, any kind of coagulopathy, malignant soft tissue diseases of any localization).
- •08. A subject should not have intolerability or allergic reaction to surgical or any medicines.
- •09. A subject who able to understand and follow instructions and participate the entire period of the clinical trial.
排除标准
- •01. A subject with known history of any Allergic reactions to sodium chloride (weight % >97), Cation copolymide (weight % <3), injectable hyaluronic acid, local topical anaesthetics or nerve blocking agents.
- •02. Subjects with traumatic scars or ongoing active skin disease in the area to be treated.
- •03. A subject with history of any type of cancer.
- •04. A subject with history of advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
- •05. Permanent implant or filler, including fat injection placed in the area to be treated.
- •06. A subject have any disease, including uncontrolled diabetes (e.g., Hb A1c > 8%), that is clinically known to impact wound healing ability.
- •07. A subject shows tissue characteristics that are clinically incompatible with mammoplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration.
- •08. A subject have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems).
- •09. Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steroidal anti-inflammatory drugs, acetylsalicylic acid, omega 3 and Vitamin E), chemotherapy, immunosuppressive agents, immune-modulatory therapy (e.g. monoclonal antibodies), systemic or topical corticosteroids (Inhaled corticosteroids are allowed) within 02 weeks prior to screening visit.
- •10. A subject who are not willing to undergo further surgery for revision, if medically required.
- •11. A subject with history of tissue augmentation therapy within 12 months prior to screening visit.
- •12 . A subject who had undergone procedures based on active dermal response (e.g., laser or chemical procedures) within 06 months prior to screening visit.
- •13. A subject with bleeding disorders or HIV or anaplastic large cell lymphoma.
- •14.A subject who has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure.
- •15. A subject with history of lower extremity thrombosis or post-thrombosis syndrome.
- •16. A subject with vascular disorder (e.g., varicose veins).
- •17. A subject with history of or the presence of any skin condition/disease in the treatment area that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- •18. A subject with an active bacterial, fungal, or viral infection in the treatment area.
- •19. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
- •20. Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g., a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
- •21. Works for BioDev Services Private Limited, the study surgeon, or study sponsor that is helping to conduct the study or are directly-related to anyone that works for CRO and/or sponsor.
研究者
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