NCT05540821 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Exacoustos C, Malzoni M, Di Giovanni A, Lazzeri L, Tosti C, Petraglia F, Zupi E
Ultrasound mapping system for the surgical management of deep infiltrating endometriosis. Fertil Steril. 2014 Jul;102(1):143-150.e2. doi: 10.1016/j.fertnstert.2014.03.043. Epub 2014 Apr 29.
Leonardi M, Espada M, Lu C, Stamatopoulos N, Condous G
A Novel Ultrasound Technique Called Saline Infusion SonoPODography to Visualize and Understand the Pouch of Douglas and Posterior Compartment Contents: A Feasibility Study. J Ultrasound Med. 2019 Dec;38(12):3301-3309. doi: 10.1002/jum.15022. Epub 2019 May 15.
Nisenblat V, Bossuyt PM, Farquhar C, Johnson N, Hull ML
Imaging modalities for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Feb 26;2:CD009591. doi: 10.1002/14651858.CD009591.pub2. Review.
Taylor HS, Kotlyar AM, Flores VA
Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. Lancet. 2021 Feb 27;397(10276):839-852. doi: 10.1016/S0140-6736(21)00389-5. Review.
Tuttlies F, Keckstein J, Ulrich U, Possover M, Schweppe KW, Wustlich M, Buchweitz O, Greb R, Kandolf O, Mangold R, Masetti W, Neis K, Rauter G, Reeka N, Richter O, Schindler AE, Sillem M, Terruhn V, Tinneberg HR
[ENZIAN-score, a classification of deep infiltrating endometriosis]. Zentralbl Gynakol. 2005 Oct;127(5):275-81. Review. German.

Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis: a Prospective Diagnostic Test

Clinical trial NCT05540821 - References