EXPERIENCE WITH SCIENTIFIC STUDIES

Actual:

PRINCIPLE INVESTIGATOR:
  • PREG 1 study: Prevention of intrauterine adhaesions after hysteroscopic surgery with Womed Leaf ( a novel tri-block deGradable polymerfilm)

LOCAL COORDINATOR MULTICENTRE STUDIES:
  • AltaSeal Study: FDA and CE study, new hysteroscopic sterilization technique

MEMBER INDEPENDANT "CLINICAL EVENTS COMMITTEE" (CEC):
  • "Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids"
Past:

PRINCIPLE INVESTIGATOR:
  • AEGEA: Phase II Feasibility Clinical Study of the AEGEA GEA System in Women With a History of Menorrhagia
  • AltaSeal Study (fase 1 new hysteroscopic sterilization technique: peri-hysterectomy study)
  • Pilot study Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
  • IPSIS (Intra Peritoneal Saline Infusion Sonography) study: IPSIS vs. diagnostic laparoscopy in diagnosing intra-abdominal adhaesions
  • Reproduciblity of saline infusion sonohysterography for the detection of intracavitary pathology in women with abnormal uterine blood loss. An observational study.

LOCAL COORDINATOR MULTICENTRE STUDIES:
  • TCRM study: The effect of transcervical resection of submucous fibroids in the treatment of heavy menstrual bleeding - TCRM study, a multicentre prospective cohort study
  • Esmya study: Observational postmarket study: clinical evaluation of effectivity and adverse effects of an EMA approved drug: ulipristal (Esmya®)
  • Hys Niche study: Hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a prospective randomized controlled multicentre trial
  • Essure TVU study: Use of Transvaginal Utrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of effectiveness
  • Morcellator TUD: Observational study of objective morcellator related data in laparoscopic surgical procedures
  • PAPA study: Post abortion prevention of adhesions: evaluation of hyaluronic acid (Hyalobarrier® gel endo), a prospective randomized controlled multicentre study
  • TRUST study: The Randomised Uterine Septum Transsection trial, a prospective randomized controlled multicentre trial to evaluate reproductive outcome after surgical intervention (hysteroscopic metroplasty) in women with subfertility and/or recurrent miscarriage and a septate uterus
  • ESEP Study (RCT tubotomie vs. tubectomy in ectopic pregnancy)
  • Ikherstel Study (RCT new way of providing postoperative information vs supply of conventional information)
  • Ligasure study (RCT ligasure vs. conventional suturing technique in vaginal hysterectomy)
  • TLH study: laparoscopy vs. laparotomy for the treatment of early stages of endometrial cancer: a multi-centre cost effectiveness
  • Essure insertion in IUD users: A European multicentre study.
  • Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial), RCT
  • A double-blind, placebo-controlled, 3-arm fixed dose study of paroxetine CR intermittend dosing (12,5mg and 25mg) for Premenstrual Dysphoric Disorder
  • A multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the safety, tolerability and efficacy of the CCR1 antagonist ZK 811752, given orally in a dose of 600 mg three times daily, for the treatment of endometriosis over 12 weeks
  • A Prospective, Randomized, Post-Market Study to Compare the Performance of SprayGel® Adhesion Barrier System to Good Surgical Technique in the Prevention or Reduction of Post-Operative - Adhaesion Formation in the Pelvic Cavity Following Laparoscopic Gynecological Surgery
  • AZTEC trial: Gosereline Acetate (Zoladex) as additional treatment in endometrial ablation for dysfunctional uterine bleeding, a multicentre dubbel blind RCT
  • IUR Reciprocating Hysteroscopic Morcellator Clinical Evaluation
  • LapTop! Study: observational study of laparoscopic surgery and complications.
  • National clinical observational study of Essure sterilization: reliability, complications, pain scores
  • National clinical observational study of Adiana sterilization: reliability, complications, pain scores
  • Vesselseal study: Perioperative outcomes using LigaSure compared with conventional bipolar instruments in laparoscopic hysterectomy: a randomised controlled trial.