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Prospective randomized trial to evaluate and to compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.

1. To evaluate and compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.2. It is still uncertain whether laparoscopic salpingectomy for hydrosalpinx…

STATEC: A randomised trial of non-selective versus selective adjuvant therapy in high risk
endometrial cancer

To determine the clinical effectiveness of adjuvant therapy given to all unstaged (no lymph node dissection) high risk stage 1 endometrial cancer, compared with only node positive (staged) cases as judged by full lymph node dissection.

Pivotal Study for Safety & Efficacy of AltaSeal® A Hysteroscopically Placed Mechanical Occlusion Implant for Hysteroscopic Sterilisation

The primary objective of this clinical trial is to evaluate the safety and effectiveness of the AltaSeal® implants in providing bilateral mechanical occlusion of the fallopian tubes and in preventing pregnancy.Additional objectives are as follows:*…

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…

Sentinel node biopsy in Low- and Intermediae endometrial cancer Management: The SLIM-study

1. To assess the feasibility of SLN identification in endometrial cancer.2. To examine in how many cases SLN biopsy provides results that will tailor adjuvant treatment3. To investigate if SLN biopsy in women with low- and intermediate-risk…

Sentix: A prospective observational trial on sentinel lymph node biopsy in patients
with early stage cervical cancer

To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the…

Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy

The primary objective of this study is to examine whether MIS is non-inferior to laparotomy in terms of disease free survival (DFS) in women with advanced stage EOC that received 3 to 4 cycles of NACT.

A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

Primary* To confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian…

Advanced Pivotal Study for Safety & Efficacy of AltaSeal® a Hysteroscopically Placed Mechanical Occlusion Implant for Hysteroscopic Sterilisation

The primary objective of this clinical trial is to evaluate the safety and effectiveness of the AltaSeal® implants to provide bilateral mechanical occlusion of the fallopian tubes resulting prevention of pregnancy.

STATEC: A randomised trial of non-selective versus selective adjuvant therapy in high risk apparent stage I endometrial cancer

To determine the clinical effectiveness of adjuvant therapy given to all unstaged (no lymph node dissection) high risk stage 1 endometrial cancer, compared with only node positive (staged) cases as judged by fulllymph node dissection.