Clinical Investigation To Evaluate Cerviron Ovules® in Cervix Lesions Postoperative Care
Condition: Cervical Lesion
MeSH terms: Uterine Cervical Diseases
Study type: Interventional

Summary: 
      CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate
      the Performance and Safety of Cerviron® Ovules in Cervix Lesions Postoperative Care. The
      primary objective is to assess the therapeutic performance and tolerability of Cerviron®
      Ovules in postoperative care in patients that underwent surgical removal of benign, cervical
      lesions. The secondary objective of this clinical investigation is the assessment of
      performance of the medical device by clinical exam and patients' degree of satisfaction
      related to the use of the medical device.
    

Detailed description: 
      Identifying premalignant and benign diseases of the cervix and selecting an appropriate
      treatment path can be challenging. The adult uterine cervix may exhibit a wide variety of
      pathologic conditions that include benign entities (eg, cervicitis, hyperplasia, nabothian
      cysts, cervical polyps, leiomyomas, endometriosis, and congenital abnormalities) as well as
      malignant lesions, particularly cervical carcinoma.

      Cervical lesions range from being visible only with an instrument that augments sight such as
      a colposcope to being visible by speculum examination or endovaginal ultrasound.

      The most frequent types of cervical lesions are:

      1. Cervical polyp Cervical polyps are benign growths, usually protruding from the surface of
      the cervical canal. They commonly occur during the reproductive years, especially in women
      over 20 years of age. Cervical polyps are the most common non-cancerous tumour of the cervix.

      The cervical polyps may vary in size, shape, and origin. They can present as single or
      multiple, tear-shaped or lobular, cherry-red, or greyish-white in color, depending on the
      vascularity of the lesion. The size of the cervical polyp is typically less than three cm in
      diameter; however, as mentioned earlier, they can vary in size and can be large enough to
      fill the vagina or be present at the introitus They usually originate in the endocervical
      canal. Endocervical polyps may be caused by chronic inflammation. They rarely become
      malignant.

      Nabothian cyst Nabothian cysts are a benign gynecological condition in reproductive age
      without clinical significance. These cysts are at the squamocolumnar junction of the uterine
      cervix, which is the targeted anatomical area of brush sampling at the time of cervical
      screening cytology. They are filled with mucus, but they may also contain proteinaceous
      material, neutrophils, or neutrophil debris. These cysts usually appear superficially and are
      easily recognized during colposcopy examination. If left untreated, they can induce
      considerable enlargement of the cervix, which can lead to symptomatology. Other causes of
      these large cysts include cystic degeneration of uterine leiomyoma and congenital uterine
      cysts such as mesonephric and paramesonephric cysts and cystic adenomyosis.

      Complications of Nabothian cysts include hematometra, labor passage obstruction, rectal
      compression, abnormal uterine bleeding, specifically in case of giant cysts, and chronic
      urinary retention by restricting the bladder's outlet or by compressing the pudendal and
      sacral nerves, thus, disturbing the nerve supply to the detrusor muscle.

      Cervical fibroid Cervical fibroids (myomas) start in the muscle tissue of the cervix. They
      are similar to uterine fibroids but less common. Cervical fibroids may not cause symptoms.
      The most common symptom is abnormal vaginal bleeding. Pain during intercourse may happen. If
      the fibroid becomes large, it may partially block the urinary tract and cause urinary
      drainage problems such as dribbling or urinary retention. If myomas become infected, they may
      cause pain, bleeding, or a discharge from the vagina.

      The recommended treatment in all cases is excision. After surgery, haemostasis and rapid
      recovery should be promoted with the support of local, re-epithelizing treatments.

      Cerviron® ovules Cerviron® ovules is a class IIb medical device used as adjuvant treatment in
      cervical lesions of mechanical origin. It favors the healing and re-epithelialization
      processes and reduces the proliferation of endogenous pathogens.

      Bismuth subgallate causes shrinkage of damaged tissue by stopping bleeding and promoting
      tissue healing. Being an insoluble salt and very little absorbed the bismuth subgalate forms
      a protective film that allows the other components to act locally. "Through its active
      ingredient, Bismuth subgallate, Cerviron® ovules exert a protective action on mucous
      membranes and raw surfaces. Moreover, it provides a strong hemostatic effect, as shown in
      multiple studies. Moreover, it contains collagen with nutritive, hydrating, healing and
      trophic effect. Collagen is structurally and functionally a key protein of the extracellular
      matrix which is also involved in forming the scars during the healing of conjunctive tissues,
      due to its chemotactic role. Many collagen bandages were developed to improve the repair of
      the wound, especially of non-infected, chronic, idle cutaneous ulcerations.

      The Marigold extract (Calendula Officinalis) contains as active principles carotenoid
      substances, triterpenic compounds and volatile oil, favouring a healing, antitricomonazic
      effect and reducing the excessive secretion (leucorrhea). Flavonoids and triterpene
      glycosides boast soothing properties and also help improve microcirculation. Marigold is
      mainly used for treating skin disorders: irritation, redness and inflammation. The plant was
      employed in the civil war to treat wounds.

      This is the second clinical investigation on human subjects with this medical device, in
      which 50 patients will be enlisted, and which will take place in two research centres in
      Romania.
    

Intervention name(s): Cerviron
Intervention type(s): Device
Intervention description(s): Cerviron® ovules is a class IIb medical device used as adjuvant treatment in cervical lesions of mechanical origin. It favors the healing and re-epithelialization processes and reduces the proliferation of endogenous pathogens.
Moreover, it provides a strong hemostatic effect, as shown in multiple studies. Moreover, it contains collagen with nutritive, hydrating, healing and trophic effect. Collagen is structurally and functionally a key protein of the extracellular matrix which is also involved in forming the scars during the healing of conjunctive tissues, due to its chemotactic role. Many collagen bandages were developed to improve the repair of the wound, especially of non-infected, chronic, idle cutaneous ulcerations.
Intervention model: Single Group Assignment
Intervention model description: A Prospective, Open-Label, Pilot, Multicentric Clinical Investigation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical lesion