Benign, Premalignant and Malignant Gynecological Disease Confined to the PelvisPhase 2OB-ALFXNCT02338505
Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX
A Phase 2 study testing Telelap ALF-X in people with Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Phase II prospective single-institutional study. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis
- What is being tested?
- Telelap ALF-X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- 30 ≤ BMI < 40
- ASA < III
- Ovarian Cyst
- Prophylactic bilateral salpingo-oophorectomy
- Ectopic Pregnancy
Show all 14Show fewer
- Pelvic Inflammatory Disease
- Sterility/Infertility
- Benign uterine disease (fibromatosis, adenomyosis)
- Endometrial hiperplasia
- Early-stage Endometrial Cancer
- Preneoplastic lesions of the cervix
- IA1 Cervical Cancer
- Pelvic endometriosis
Who cannot join
- Pregnancy
- Liver disease
- Coagulopathies
- Clinical conditions contraindicating laparoscopy
Trial locations and contacts
1 site in 1 country.
Salvatore Gueli Alletti, MD contact
Salvatore Gueli Alletti, MD contact
Italy1 site
Catholic University of Sacred Heart Rome,
Rome, Rome, 00168
Giovanni Scambia, Professor, +39-06-30156279, giovanni.scambia@rm.unicatt.it
Giovanni Scambia, Professor
About this study
Phase II prospective single-institutional study.
Read the detailed description
The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.
- Being tested
- Telelap ALF-X
- Keywords
- Robotic Surgery, Telelap-ALFX, Gynecological disease
- Medical subject headings
- Precancerous Conditions, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telelap ALF-XDevice
Also called ALF-X teleassisted surgery
Patients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit.
Through the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Telelap ALF-X in obese patients with gynecological disease | Experimental | Not described Receives: Device: Telelap ALF-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complication rate
Operative time, conversion rate, estimated blood loss, visceral injury
Measured: intraoperative
Secondary outcomes (1)
postoperative complication rate
Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign, Premalignant and Malignant Gynecological Disease Confined to the PelvisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- SOFAR S.p.A.
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338505
- Sponsor's protocol ID
- 21264/14
- Acronym
- OB-ALFX
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gidaro S, Buscarini M, Ruiz E, Stark M, Labruzzo A. Telelap Alf-X: a novel telesurgical system for the 21st century. Surg Technol Int. 2012 Dec;22:20-5.
PubMed 23225591Gidaro S, Altobelli E, Falavolti C, Bove AM, Ruiz EM, Stark M, Ravasio G, Lazzaretti SS, Maurizio B. Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study. Surg Technol Int. 2014 Mar;24:35-40.
PubMed 24706079Lococo A, Larocca V, Marino F, De Filippis AF, Cesario A, Lococo F. Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model. Surg Innov. 2015 Jun;22(3):252-6. doi: 10.1177/1553350614549633. Epub 2014 Sep 15.
PubMed 25225214Falavolti C, Gidaro S, Ruiz E, Altobelli E, Stark M, Ravasio G, Ravasio G, Lazzaretti SS, Buscarini M. Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study. Surg Technol Int. 2014 Nov;25:37-41.
PubMed 25433265
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX
- ClinicalTrials.gov ID
- NCT02338505
- Acronym / sponsor ID
- OB-ALFX / 21264/14
- Keywords
- Robotic Surgery, Telelap-ALFX, Gynecological disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- SOFAR S.p.A.
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II prospective single-institutional study.
Detailed description
The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telelap ALF-X in obese patients with gynecological disease | Experimental | Device: Telelap ALF-X |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- informed consent
- 30 ≤ BMI < 40
- ASA < III
- Ovarian Cyst
- Prophylactic bilateral salpingo-oophorectomy
Key exclusion criteria (4 listed)
- Pregnancy
- Liver disease
- Coagulopathies
- Clinical conditions contraindicating laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telelap ALF-XAlso: ALF-X teleassisted surgeryPatients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit. Through the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure. | Device | Telelap ALF-X in obese patients with gynecological disease |
Primary outcome
intraoperative complication rate
Time frame: intraoperative
Operative time, conversion rate, estimated blood loss, visceral injury
1 secondary outcome
postoperative complication rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Results publication: PubMed 23225591Gidaro S, Buscarini M, Ruiz E, Stark M, Labruzzo A. Telelap Alf-X: a novel telesurgical system for the 21st century. Surg Technol Int. 2012 Dec;22:20-5.
- Results publication: PubMed 24706079Gidaro S, Altobelli E, Falavolti C, Bove AM, Ruiz EM, Stark M, Ravasio G, Lazzaretti SS, Maurizio B. Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study. Surg Technol Int. 2014 Mar;24:35-40.
- Results publication: PubMed 25225214Lococo A, Larocca V, Marino F, De Filippis AF, Cesario A, Lococo F. Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model. Surg Innov. 2015 Jun;22(3):252-6. doi: 10.1177/1553350614549633. Epub 2014 Sep 15.
- Results publication: PubMed 25433265Falavolti C, Gidaro S, Ruiz E, Altobelli E, Stark M, Ravasio G, Ravasio G, Lazzaretti SS, Buscarini M. Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study. Surg Technol Int. 2014 Nov;25:37-41.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Gueli Alletti, MD contact
Salvatore Gueli Alletti, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telelap ALF-X in people with Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Gueli Alletti, MD (gueliallettis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative complication rate (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02338505, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.